FREQUENTLY ASKED QUESTIONS
Q: What is Embryo Adoption?
A:Embryo adoption is the process of adopting frozen embryos from their donor parents (or genetic donors)
and implanting them in the adoptive mother’s uterus via in vitro fertilization (IVF).
human embryo on a pin
DR YORGOS NIKAS / SCIENCE PHOTO LIBRARY
Q: How successful is Embryo Adoption?
A:Donated embryos face several hurdles before a successful birth. First, the embryos must survive the thawing process and then the transfer. At that point, they are subject to the same challenges of any typical pregnancy.
National statistics are 40% chance of thaw 50% chance they will
"stick" Using the vitrification process 70-95% chance of thaw with 50%
chance they will stick.
Q: What is the current supply of frozen embryos?
A: Reports indicate there are about 400,000 frozen embryos stored in fertility clinics around the country.
How many of those are reserved for failed IVF patients, donated to
clinics by successful IVF patients who are not told about the open or
agency option of an agency like Embryos Alive is not known. Embryos
Alive is researching donors to find out what helps them make their
decision to donate.
Again, only half of those embryos are expected to survive upon thawing (grade one and two embryos). Unfortunately, many embryo donors do not want to make their embryos available for adoption. Like traditional adoptions, there is a waiting list to adopt the embryos. Once again, demand is greater than the supply.
Q: Are embryos alive?
Q: How long can embryos be stored?
A: With the rapid advances in reproductive medicine,
cryopreserved or frozen embryos can remain viable, potentially, for an
indefinite period of time. Pregnancies with good outcomes have been
reported following thawing and transfer of embryos frozen for over a
decade. Hundreds of healthy babies conceived from frozen embryos are
born every year. And the numbers continue to increase. Excerpt from
Fairfax Cryobank website
http://www.fairfaxcryobank.com/emstorage.aspx April 14, 2009
Q: What will happen to those embryos that are not adopted?
A: Embryo donors are given the choice of destroying the embryos or releasing them for medical research.
At this time it is not known how long embryos can be stored. As long as
they are maintained in liquid nitrogen they could be stored
Q: What is the cost of embryo adoption?
A: Surprisingly, the cost of embryo adoption is much less than the cost of traditional after-birth adoptions. Most embryo adoptions cost between $7,000-$10,000 and include the transfer of the embryos to the adoptive mother’s uterus. The remainder of the fee is used to reimburse the genetic couple for their lab and storage expenses. Most traditional adoptions – as well as most IVF procedures – easily cost between $20,000-$30,000.
Q: What are the legal ramifications of embryo adoptions?
A:Embryo adoptions are strictly legal, as there are currently no laws governing the process
although recently Georgia passed a personhood bill. A legal and binding agreement is written between all parties involved and once the embryos are transferred, the genetic couple cannot change their minds.
Parents are given the option of "readoption" once a baby is born
through their county court system.
Q: What do the donors and adoptive parents know about one another?
A:Much like traditional post-birth adoptions, embryo adoptions can be open, closed.
email option or agency-liaison. While many genetic couples or donor parents wish to remain anonymous, the adoptive couple
may request a social medical history and their clinic is provided with
any medical and or psychological information requested. And in most of the cases, the genetic couple selects the adoptive couple, based on personal information that is provided in the couple’s
profile. There are also many cases where the couples exchange names and e-mails, and meet before the transfer and continue an open relationship once the child is born.
Q: Why would a couple choose to donate their embryos?
A: Because IVF is a painful and expensive procedure, doctors choose to harvest and fertilize numerous eggs for multiple attempts at a pregnancy. Often, several embryos are frozen for future use. Of course, couples never intend to parent that many children, so they are left with the agonizing decision of what to do with the remaining embryos. Their choices are to destroy them, donate them to medical research or offer them to another couple for adoption. Those parents who choose to offer their embryos for adoption believe that it’s best to give life a chance.
Q: How many embryos are transferred at one time?
A:SART Society for Reproductive Technology guidelines request that doctors transfer two to three embryos at a time depending on the age of the DONOR at the time of cryopreservation.
Is Single Embryo Transfer the Solution?
In an attempt to reduce multiple pregnancy rates, many investigators, especially in Europe, have become strong proponents of single embryo transfer. Indeed, a number of recent studies have demonstrated that in carefully selected patients, the transfer of only one embryo, followed, in case no pregnancy is established, by a single embryo transfer of a frozen-thawed embryo, will result in a cumulative pregnancy rate for both of these cycles. This is statistically comparable to the pregnancy rate achieved if two embryos are transferred in an initial cycle. The repeat single embryo transfer cycles achieve this cumulative pregnancy rate, however, overwhelmingly through the establishment of singleton pregnancy, while in the two-embryo transfer cycles a very high twin pregnancy rate is unpreventable.
Two studies at the recent annual meeting of the American Society for Reproductive Medicine in Philadelphia and a recent publication in the prestigious New England Journal of Medicine quite convincingly made the point that twin pregnancies, following IVF, can be indeed dramatically reduced if a single embryo transfer policy is followed in appropriately selected patients. However, all of these data involved only young women with apparently entirely normal ovarian function. Proper patient selection is, therefore, an absolute prerequisite and single embryo transfer is only an option for a relatively small number of infertility patients. At CHR, the pool of qualified patients would probably be only approximately 5% of the total patient population.
Nobody argues with the fact that high order multiple pregnancies should be avoided at almost any cost. The risk of significant prematurity with triplet and even higher order pregnancies is simply too great. And significantly premature infants are at very high risk for permanent neurological damage, an outcome we simply have to prevent. Twin pregnancies, while still at somewhat increased risk in comparison to singletons, can, however, in an overwhelming majority of cases be delivered safely. And, indeed, as we in a study of hundreds of infertility patients reported a number of years ago, and as other studies since have reconfirmed, infertility patients in a large majority are desirous of twins, especially if they are older and have experienced longstanding infertility. In deciding on single embryo transfer we, at CHR, therefore, of course, will take the wishes of our patients into account.
Sequential single embryo transfer also increases costs because it adds, in case of failure, the cost of a second frozen-thawed embryos transfer cycle. The argument of proponents for single embryo transfer is that this added cost is minute in comparison to the potential medical costs that can arise from the premature delivery of infants after a multiple embryo transfer. And, while this argument is economically correct, patients will often not be willing to accept it.
Q: Is there an increased risk of birth abnormalities?
A:The risk of birth abnormalities is no greater in embryo adoption than in a couple’s own genetic pregnancy.
Q: Are you licensed?
A: We are Inc. in the state of Ohio as a L.L.C. Limited Liability
Q: Are all stem cells embryo stem cells?
A:Stem Cell Researchers only point to embryo stem cells for research.
Stem Cell Research
Stem Cells are very unique cells. Stem Cells have the amazing ability to develop into several distinct cell types in the body. Thus Stem Cells can be used as a repair system for the body. Stem Cells can theoretically divide without limit in a living human or animal in order to replenish various types of cells. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function (i.e. a muscle cell, a red blood cell, a brain cell, etc.). All Stem Cells have the same three general properties as follows:
Stem Cells can divide and renew themselves for long periods of time
Stem Cells are unspecialized
Stem Cells can divide and become specific specialized cell types of the body
Stem Cell Research is being conducted on both Adult Stem Cells and Embryonic Stem Cells.
An Adult Stem Cell is an Undifferentiated Cell found among differentiated cells in a tissue or an organ. Adult Stem Cells can renew themselves and can differentiate themselves to become the major specialized cell types of a tissue or an organ. The principal roles of Adult Stem Cells in a living organism are to maintain and repair the tissue in which they are found. Some scientists now use the term Somatic Stem Cell instead of Adult Stem Cell. Bone marrow contains at least two kinds of stem cells. One Stem Cell type, called a hematopoietic stem cell, forms all the types of blood cells in the body. A second Stem Cell type, called a bone marrow stromal cell (mesenchymal stem cells), is a mixed cell population that generates bone, cartilage, fat, and fibrous connective tissue. The brain does contain stem cells that are able to generate the brain's three major cell types, which are as follows:
astrocytes (non-nerve cells)
oligodendrocytes (non-nerve cells)
neurons (nerve cells)
The possibility exists that stem cells from one tissue may be able to give rise to cell types of a completely different tissue, a phenomenon known as plasticity or transdifferentiation (i.e. blood cells becoming neurons). Unlike Embryonic Stem Cells, which are defined by the blastocyst inner cell mass, the origin of adult stem cells in mature tissues is unknown.
Embryonic Stem Cells are derived from embryos that develop from eggs that have been fertilized in vitro (in an in vitro fertilization clinic) and then donated for research purposes with informed consent of the donors. Embryonic Stem Cells are never derived from eggs fertilized inside of a woman's body. The embryos from which Human Embryonic Stem Cells are derived are typically four or five days old and are a hollow microscopic ball of cells called the blastocyst. The blastocyst includes the following three structures:
trophoblast (a layer of cells that surrounds the blastocyst)
blastocoel (a hollow cavity inside the blastocyst)
inner cell mass (a group of approximately 30 cells at one end of the blastocoel)
Q: What is the regulatory Environment for ART?
A: About fifteen percent of women of childbearing age in the United States have received an infertility service (e.g., medical tests to diagnose infertility, treatments to help a woman become pregnant, and services to prevent miscarriage) at some point in their lives.1 Since 1981, when the first baby in the United States was born as a result of in vitro fertilization (IVF),2 the use of IVF and related procedures (collectively referred to as assisted reproductive technology or ART) has continued to rise. In 1999, about 90,000 IVF procedures comprised 98 percent of all types of ARTs performed.3 Although these technologies initially were developed to help individuals who had difficulty conceiving or carrying a pregnancy to term, IVF has also more recently been used in conjunction with preimplantation genetic diagnosis (PGD) for fertile couples at risk of having a child with a genetic disease.
According to 1999 data compiled by the Centers for Disease Control and Prevention (CDC), the "success rate" for ART using fresh, nondonor eggs or embryos is approximately 25 percent.4 This means that, for each cycle of ART attempted, 1 in 4 women will give birth to at least one live baby. The success rate varies depending on a variety of factors, including a woman's age, the cause of the infertility, the type of procedure used, and the clinic performing the procedure.
ART patients are more likely to deliver multiple infants than women who conceive without treatment. These multiple-infant births are associated with increased risks for pregnancy complications, premature delivery, low birth-weight infants, and long-term disability among surviving infants.5 The use of ART is increasing in most states and the majority of infants born as a result of these procedures are multiple births.6 There are also preliminary data showing that children born as a result of ART are more likely to have birth defects and low birth weight, even if they are not the products of multiple births.7 However, it is not clear if these complications are the result of the treatments used or the underlying infertility itself.
Regulation of ART Clinics and Laboratories
1. The Clinical Laboratories Improvement Amendments of 1988 (back to top)
ART laboratories that perform diagnostic tests, such as analysis of semen or blood, must be certified under the federal Clinical Laboratories Improvement Amendments of 1988 (CLIA).8 Regulations issued by the Centers for Medicare and Medicaid Services (CMS), which administers the CLIA program, include provisions addressing quality control and assurance, educational and professional qualifications for technical and supervisory staff, and inspection and enforcement procedures.9 Among other provisions, these regulations require that laboratories establish and follow written quality control procedures described in a procedures manual, and maintain records of all quality control activities. The laboratory’s manual must also include remedial action policies and procedures. The regulations also provide for federal officials to perform announced or unannounced inspections and employee interviews. In addition, the regulations contain provisions for enforcement and permit the imposition of sanctions on noncomplying laboratories.
CLIA requirements apply to laboratory facilities engaged in the “examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.”10 Whether and to what extent CLIA does or should apply to embryology laboratories performing ART-related tests and procedures is a matter of current debate.
2. CDC/SART (back to top)
The 1992 Fertility Clinic Success Rate and Certification Act11 requires all U.S. clinics performing ART to report data annually to the CDC for every ART procedure initiated. ART is defined as any procedure in which both oocytes and sperm are handled outside the body; these include IVF and gamete and zygote intrafallopian transfer (gametes or zygotes transferred into the fallopian tubes rather than the uterus).12 Procedures are classified according to whether the ART patient uses her own eggs or eggs donated by another woman, whether the embryos transferred were freshly fertilized or previously frozen, and whether the embryos were transferred into a gestational surrogate or a new treatment procedure was used. Clinics submit their data to CDC through the Society for Assisted Reproductive Technology reporting system. According to CDC, not all clinics in the United States that perform ART report data.13
The 1992 Act also directed CDC to develop a model program for the certification of embryo laboratories, and to encourage its adoption by states.14 The Act also directed CDC to issue criteria for approving accreditation organizations to inspect and certify embryo laboratories.15 However, the Act restricted both CDC and the states from establishing, as part of the certification program, “any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproduction technology programs.”16 In 1999, CDC issued the model program.17 The program includes standards for the performance of laboratory procedures, records maintenance, laboratory personnel qualifications, and criteria for laboratory inspection and certification. It also includes a provision by which states may qualify to adopt and administer the program if they submit an attestation to CDC agreeing to certain requirements. According to CDC, no state has submitted such an attestation, but some states may have used the model as a basis for developing their own regulations or guidelines.18
3. FDA (back to top)
ART is a medical service provided by physicians and other health care providers. As such, it constitutes part of the "practice of medicine" and is outside the scope of FDA’s regulatory authority. However, many of the materials and components used in ART are medical products subject to FDA regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act)19 and/or the Public Health Service Act (PHS Act).20 For example, medicines used to stimulate ovulation are classified as “drugs” subject to the FD&C Act and therefore must be approved by FDA before they are marketed in the United States. Similarly, culture media used to grow human embryos in the laboratory prior to implantation are classified as "devices" subject to premarket approval or clearance.21 In addition, a manufacturer seeking to conduct tests of an unapproved drug or device for human use, including drugs or devices used in ART, must file an "investigational new drug" (IND)22 or investigational device exemption (IND)23 application with FDA before beginning such tests.
FDA has also, in recent years, announced its intention to institute regulations governing reproductive tissues. In 1997, FDA issued a document articulating a comprehensive strategy for regulating "human cells, tissues, and cellular and tissue-based products" (HCT/Ps).24 The plan presents a "tiered" regulatory strategy, under which the degree of regulation required by FDA will be based on a product's potential risk. FDA included reproductive tissues within the scope of the HCT/P category. While the regulations do not explicitly define "reproductive tissues," FDA appears to intend the term to comprise semen, oocytes, and embryos.
In 2001, FDA issued a rule requiring all "manufacturers" of HCT/Ps to register with FDA and to provide a list of products manufactured.25 The agency defined "manufacture" to include tissue recovery, processing, storage, labeling, packaging, or distribution activities and tissue donor screening and testing (i.e., for communicable disease agents). FDA clarified that the rule was intended to include establishments engaged in egg donation, retrieval, semen processing, and IVF. However, an establishment that only "recovers reproductive cells or tissue for immediate transfer into a sexually intimate partner of the cell or tissue donor" (i.e., sperm retrieval for immediate insemination) is exempt from these requirements.26 Thus it appears that the registration and listing requirements will apply to at least some clinics offering ART services. The rule will become effective for manufacturers of reproductive tissue on January 21, 2004.
FDA has also stated its intention to implement other regulations that address "current good tissue practices"27 and donor suitability requirements for manufacturers of HCT/Ps.28
FDA also regulates human somatic cell therapy and gene therapy products as "biological products," and they are subject to regulation under both the PHS and FD&C Acts.29 Recently FDA sent a letter to researchers and sponsors of research informing them that FDA has the jurisdiction to regulate "human cells used in therapy involving the transfer of genetic material by means other than the union of gamete nuclei" and that FDA considered "genetic material" to include both oocytes (egg cells) and ooplasm (the material contained within an oocyte).30 Further, FDA stated that the use of such genetically manipulated cells and cellular materials in humans constitutes a clinical investigation that can only be undertaken if the sponsor has submitted an IND to FDA. This statement has had the effect, at least for the moment, of curtailing research relating to ooplasm transfer.
4. State Laws (back to top)
Some states have laws and regulations addressing ART. In general, the focus at the state level has been on ensuring informed consent for the transfer and donation of embryos.31 Several states have regulations concerning licensing and certification requirements for all health care facilities, that may also include ART programs. Some states have also enacted laws mandating health insurance coverage of infertility treatment.32
5. Professional Societies (back to top)
Some professional societies, such as the American Society for Reproductive Medicine (ASRM) issue guidelines for standards of practice and reporting as well as for topics related to treatments for infertility and gamete donation. Although these guidelines are voluntary and not part of state or federal law, they are at times viewed as evidence of standards of practice in legal settings or where evaluation of clinical practice is required.
6. Other Regulatory Issues (back to top)
There are a number of other regulatory issues related to ART. For example:
No federal law or regulation currently requires health insurance coverage of ART. Although, as mentioned above, some states have passed laws to require some degree of coverage for infertility-related services, these laws are not uniform. In addition, because health plans subject to the federal Employee Retirement Income Security Act (ERISA) are exempt from some state insurance laws, the impact of these state laws is limited.
Federal law currently prohibits the use of federal funds to conduct research on human embryos. This restriction limits researchers' ability to conduct studies of ART procedures in humans or learn more about the basic processes of human fertilization. The federal ban does not apply to research supported through private funds. Thus, research that is not supported by federal funds may not be subject to DHHS regulations for the protection of human subjects in research, such as the requirement for Institutional Review Board (IRB) review. Such research may be subject, however, to similar requirements under FDA regulations.
(back to top)
1 Centers for Disease Control and Prevention, 1999 Assisted Reproductive Technology Success Rates.
2 See H.W. Jones et al., The Program for In Vitro at Norfolk, Fertility & Sterility 38(1):14-21 (1982).
3 See Carol J. Rowland Hogue, Successful Assisted Reproductive Technology: The Beauty of One, Obstetrics & Gynecology, 100(5):1017-1019 (2002).
4 See 1999 Assisted Reproductive Technology Success Rates.
5 See Hogue, supra note 1, at 1018.
7 See, e.g., Laura A. Schieve, et al., Low and Very Low Birth Weight in Infants Conceived With Use of Assisted Reproductive Technology, New Eng. J. Med. 346(10): 731-737 (2002); Michele Hansen, et al., The Risk of Major Birth Defects After Intracytoplasmic Sperm Injection and In Vitro Fertilization, New Eng. J. Med., 346(10):725-30 (2002).
8 P.L. 100-578, 102 Stat. 2903 (1988), codified at 42 U.S.C. § 263a et seq.
9 CLIA regulations are codified at 42 C.F.R. Part 493.
10 42 U.S.C. § 263a(a).
11 P.L. 102-493, 106 Stat. 3146 (1992) (codified at 42 U.S.C. §§ 263a-1 et seq.)
12 42 U.S.C. § 263a-7(1).
13 Use of Assisted Reproductive Technology --- United States, 1996 and 1998, MMWR, 51(05);97-101(2002)
14 42 U.S.C. § 263a-2.
15 Id. § 263a-3.
16 Id. § 263a-2(i).
17 64 Fed. Reg. 39374 (July 21, 1999).
18 Telephone call with CDC personnel in Division of Laboratory Standards, Dec. 12, 2002.
19 Chapter 675, 52 Stat. 1040 (1938) (as amended), codified at 21 U.S.C. § 301 et seq.
20 Chapter 373 (1944) (codified at 42 U.S.C. § 201 et seq.). The biologics provisions of the Act are codified at 42 U.S.C. § 262.
21 See, e.g., Food and Drug Administration, Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers (May 16, 2001)
22 21 C.F.R. Part 312.
23 Id. Part 812.
24 See Food and Drug Administration, Proposed Approach to Regulation of Cellular and Tissue-Based Products (Feb. 28, 1997)
25 66 Fed. Reg. 5447 (Jan. 19, 2001) (to be codified at 21 C.F.R. § 1271.1 et seq.).
26 Id. at 5468 (to be codified at 21 C.F.R. § 1271.15(e)).
27 66 Fed. Reg. 1508 (Jan. 8, 2001) (proposed rule).
28 64 Fed. Reg. 52696 (Sept. 30, 1999) (proposed rule).
29 See Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products, 58 Fed. Reg. 53248 (Oct. 14, 1993).
30 Kathryn C. Zoon, Letter to Sponsors/Researchers - Human Cells Used in Therapy Involving the Transfer of Genetic Material By Means Other Than the Union of Gamete Nuclei, July 6, 2001.
31 See, e.g., Okla. Stat. tit. 10, § 556 (2003); La. Rev. Stat. tit. 14, § 101.2 (2002); Cal. Bus. & Prof. Code § 2260 (2001).
32 See American Society for Reproductive Medicine, State Infertility Insurance Laws.
Posted April 2003
• PGD Preliminary Policy Report
Sign up for Center
Email this page
Home | About | Genetics Information | Policy | Polls & Research
Copyright ©2005, Genetics and Public Policy Center | Web Policies
Q: What are the concerns over new FDA guidelines?
A: NEW YORK, Feb. 10 -- On May 25, 2005, new FDA guidelines for the donation of human cells, tissues, and cellular and tissue-based products (HCT/Ps), will go into effect. Reproductive tissue -- sperm, eggs and embryos -- falls under these testing guidelines. The potential impact for men and women seeking to build families through such donations will be significant.
"The American Fertility Association, always a staunch advocate of patient safety, recognizes the FDA's new guidelines as an important step forward in disease prevention. But we are concerned that the FDA does not acknowledge that reproductive tissue is distinct from all other tissues that fall under these regulations," said Pamela Madsen, Executive Director of The American Fertility Association.
As they stand, the expanded guidelines will have tremendous logistical and cost implications for patients, who often carry the burden for paying for fertility treatments in full.
Key areas of concern include:
7-Day Testing Requirement
The new FDA guidelines require donor testing for a number of diseases the FDA identifies as communicable - ranging from HIV to hepatitis -- 7 days prior to oocyte (egg) retrieval. This 7-day window seems arbitrary and has serious ramifications for gamete and embryo donors and recipients.
"The 7-day requirement is not based on clinical evidence," said Dr. Owen Davis, M.D., Medical Director for The American Fertility Association and Associate Director of the Center for Reproductive Medicine and Infertility at Cornell University Weill Medical College.
"The AFA would like to see this testing window extended to at least 14 days prior to oocyte retrieval to ensure that the results are available prior to the donor undergoing the retrieval process. This would allow timely cancellation of the donor's cycle, should she be deemed ineligible, thus avoiding the invasive retrieval process if it is not necessary," added Dr. Davis.
"It is impossible to predict the exact date when eggs are ready for retrieval, because there is no set biological timetable. Each case is unique," said Madsen. "We urge the FDA to create guidelines that help rather than hinder those trying to build families."
For example, New York State's 30-day testing requirement, the most stringent in the country, has proven efficacious in detecting disease and preventing transmission while accommodating responsible reproductive medical practices.
"The implications that these new FDA regulations hold for the future of oocyte and embryo donation cannot be ignored. We will continue to raise awareness among physicians and our patients and continue an active dialogue with the FDA to ensure that recipients of donated reproductive tissue are protected in a scientifically valid and ethically sound fashion," said Dr. Eric Surrey, M.D., President of the Society for Assisted Reproductive Technology (SART).
Future of Embryo Donation
Donor eggs or embryos were used in over 13,000 Assisted Reproductive Technology (ART) cycles carried out in 2002, slightly more than 11% of the total number, according to the Centers for Disease Control (CDC).
Beginning in May, new donors will be tested according to the FDA guidelines. However, frozen embryos will not be screened for the infectious diseases identified by the expanded FDA guidelines. Patients will be notified about their options.
The couple wishing to donate their additional embryos to other infertile couples would have to be tested during the 7-day window prior to oocytes retrieval. This adds additional costs to a cycle for those who only want to help others. Those who are not tested during the 7-day window are disqualified from donating their embryos. Their remaining options may be unacceptable -- destruction of the embryos or donating them to someone they know.
Laboratory Requirements for Labeling Specimens
Implementation of labeling requirements, which were not developed with the special needs of Assisted Reproductive Technologies in mind, may actually lead to the destruction of embryos if these particular guidelines are enforced in the future.
THE AMERICAN FERTILITY ASSOCIATION (AFA) is a national organization dedicated to educating, supporting and advocating for men and women concerned with reproductive health, fertility preservation, infertility and all forms of family building. Visit
or call 888-917-3777 for more information and support.
Q: Is there information on children conceived through IVF?
A: The American Fertility Association and RAND Launch the First Longitudinal, Prospective Study of IVF Children
'Footprints' will track the health and welfare of children conceived through in vitro fertilization (IVF)
NEW YORK, Oct. 20 /PRNewswire/ -- The American Fertility Association announces "Footprints: The IVF Children's Health Study," the first longitudinal, prospective, and scientifically objective study that chronicles the health and welfare of children conceived through IVF.
"As part of our joint responsibility to follow the children born through IVF, The American Fertility Association, in collaboration with leading reproductive endocrinologists, has identified the need for 'Footprints,'" said Pamela Madsen, Executive Director and Founder of The American Fertility Association.
There are at least 250,000 IVF children born in the U.S. to date. "Footprints" will deliver facts -- not hypotheses -- about the physical, emotional and intellectual development of this significant and growing population. Previous studies have been flawed: their data collection has been limited and their conclusions incomplete. The "Footprints" study will redress this information gap with high-quality, longitudinal data.
"Footprints" is a partnership between The American Fertility Association (formerly The American Infertility Association) and the RAND Corporation, a nonprofit research organization providing objective analysis and effective solutions that address the challenges facing the public and private sectors around the world.
The American Fertility Association and RAND Health have begun to work closely on the data collection strategies for this innovative research endeavor. This forward-looking study will track multiple gestations, birth weight, birth defects, surgical procedures, physical health, and developmental milestones for IVF children. It will also include at least one control group, the children of infertile couples conceived through Intrauterine Inseminations (IUI), and possibly others. Study methods will be designed to produce the most comprehensive and accurate data possible; implementation of the study design will be carefully monitored to ensure continuing data quality.
"'Footprints' will provide patients trying to conceive, IVF parents and their children, physicians, and allied industry with important information about the health of IVF children," said Owen Davis, M.D., AFA Medical Director and Associate Director, The Center for Reproductive Medicine and Infertility at Cornell University.
"It is critical to understand the effects of IVF on children and families. RAND is committed to working with The AFA to create a rigorous study design and oversee the integrity of its implementation. This will ensure that the data and findings from the study will be credible in the scientific community and useful to patients and their families," said Gail L. Zellman, Ph.D., RAND Senior Research Psychologist and the director of the RAND portion of the Footprints study.
"It is appropriate for this study to be a patient-driven initiative conducted by The AFA," said Ms. Madsen. "Patients have no professional bias, so having a patient-driven study avoids potential conflict of interest from a medical- or industry-led initiative."
"Given that infertility is a national public health issue, it is essential that the U.S. government provide funding to support 'Footprints,' said Richard T. Scott, Jr., AFA Scientific Director and Managing Partner of Reproductive Medicine Associates (RMA). "This study has the potential to benefit the current generation of IVF children and will also benefit future generations of these children as well."
"Footprints" is supervised by a scientific advisory committee, which assists with the planning and monitoring of the study. Advisors include AFA medical and scientific committee members, RAND analysts, reproductive endocrinologists, patient advocates, mental health professionals, epidemiologists, pediatricians, and others.
Serono, Inc. has provided The AFA with an unrestricted educational grant for "Footprints," which will serve as initial funding to assist with the development of the study design and the collection of pilot data from a cross-section of U.S. IVF centers. The AFA and the RAND Corporation will seek federal funding for "Footprints," enabling it to become an expanded national study.
"'Footprints' is a bold first step and, as an IVF mother, this is the best gift I could ever give to my children," added Ms. Madsen.
Q: Is single embryo transfer a good option?
A: Betting on single embryo in vitro not a bad gamble
Procedure improves so couples need not risk multiple births
By JULIE DAVIDOW
SEATTLE POST-INTELLIGENCER REPORTER
Four years into her quest to get pregnant, after she had decided to try in vitro fertilization, 35-year-old Lisa Goss had a decision to make.
Did she want one or two embryos put back in her uterus?
With two, she might have twins; with one, she might be reducing her odds of having a baby at all.
Doctors used to routinely place two, three, four and five embryos after in vitro fertilization.
Grant M. Haller / P-I
Lisa and Erick Goss of Seattle check out their 3-month-old daughter, Greta, in her crib at home yesterday. Lisa opted for single-embryo transfer at Seattle Reproductive Medicine after four years of failed fertility treatments. The procedure worked. "I never knew if I made the right decision," Lisa said of getting just a single embryo implanted. "Until I got the pregnancy test, I was very nervous."
But with better techniques for growing and selecting the best quality embryos, fertility specialists have started offering some patients the option of avoiding the complications of multiple births by betting on a single embryo.
"Years ago when we were doing IVF, it seemed like the pregnancies were so few and far between you didn't worry," said Dr. Michael Soules of Seattle Reproductive Medicine, a private clinic opened last year by a crew of fertility specialists. "You transferred a bunch of embryos and hoped one would take."
Since 1981, 114,000 babies have been born using in vitro, according to the American Society for Reproductive Medicine. The procedure involves combining egg and sperm in a lab dish to create embryos, which can then be transferred to a woman's uterus. Any extra viable embryos can be frozen for later use.
Relatively young and trying in vitro for the first time, Goss was the ideal candidate for success with one embryo.
Some studies suggest comparable pregnancy rates for young women who receive one or two embryos, but there's not enough data yet to give women a definitive answer.
And although Goss' other embryos would be frozen, the fresh ones have a better chance at success.
"I never knew if I made the right decision. Until I got the pregnancy test, I was very nervous," said Goss, who as a patient at Seattle Reproductive Medicine was enrolled in the single-embryo study.
Her daughter, Greta, is now 3 months old. She's on the brink of sleeping through the night, but two hours of uninterrupted rest is all Goss can count on for now.
She can't imagine having twins.
"I think I'd ask my in-laws to move in," Goss joked.
But the stress and additional work of caring for more than one baby is just one of the potential drawbacks of multiple births, say doctors.
In a recent survey of 449 women being treated for infertility, 20 percent said they would prefer multiples to a single baby. Less than half were aware of the health problems associated with twins, including an increased risk of cerebral palsy and low birth weight, according to researchers at the University of Iowa, who published the results last March in the journal of Fertility and Sterility.
Still, many couples, after years of waiting and hoping for a child, are more than happy to have twins.
Unlike countries in northern Europe, where single-embryo transfers have been common for years and national insurance programs cover in vitro, couples in the United States must often pay for the $12,000 procedure on their own.
Only 16 states (not including Washington) require insurers to pay for fertility treatments.
The financial burden added to the emotional cost of repeated IVF cycles, which take weeks, including hormones and egg retrieval, can rapidly drain a couple's resources.
Goss and her husband, Erick, were committed to one IVF cycle.
"We said let's try this ... and if it doesn't work, let's go for adoption," Goss said.
Because IVF is considered the last resort after years of failed attempts to have a baby, some women aren't willing to take even a slightly higher risk of failure, said Dr. Lori Marshall, a reproductive endocrinologist at the Center for Fertility and Reproductive Endocrinology at Virginia Mason Medical Center.
Only a handful of women have opted for a single-embryo transfer in the two years since the clinic began presenting the option to patients, said Marshall.
"We tell them, if we put two back in, there's a risk of twins. It may be 30 to 40 percent. And they say, that's fine. We'd love to have twins."
While parents might not be concerned, doctors are feeling the pressure to reduce multiple births from within their profession, said Dr. David Adamson, medical director at Fertility Physicians of Northern California and a member of the board of the Society for Assisted Reproductive Technology, an organization of reproductive physicians.
The American Society for Reproductive Medicine for the first time last year advised doctors to consider using one embryo for women who have the best chance of getting pregnant.
In an increasingly crowded IVF market, some clinics are offering financial incentives they say could encourage women to try single-embryo transfers.
Seattle Reproductive Medicine offers a more expensive plan with a partial money-back guarantee for patients who don't get pregnant with IVF. Adamson belongs to a national network of physicians that markets a package of IVF services, including a free frozen embryo cycle.
And doctors at Virginia Mason, who handle egg retrievals and embryo transfers for patients at Madigan Army Medical Center, are putting together a proposal asking Madigan to cover a portion of the cost of IVF, Marshall said.
Meanwhile, physicians at Seattle Reproductive Medicine say they've already been able to achieve high pregnancy rates for single-embryo transfers.
By selecting the best candidates, including Goss, and transferring more mature embryos, called blastocysts, 76 percent of women with single embryos got pregnant, compared with 78 percent of those who received two.
Most fertility specialists consider 50 to 55 percent pregnancy rates respectable. The clinic's data have not yet been accepted for publication.
"We need to loosen our criteria and see how far we can back off and still get the same pregnancy rate," Soules said.
P-I reporter Julie Davidow can be reached at 206-448-8180 or
Q: Could a frozen cycle be better than a fresh cycle?
A: Frozen embryos may yield better pregnancy outcomes
Last Updated: 2005-07-01 11:40:42 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Low birth weight (LBW) and preterm birth are more frequent in babies born through assisted reproductive techniques (ART), a study from Australia shows. The study also shows that use of fresh rather than frozen embryos appears to be one risk factor for these outcomes.
The number of births after the use of ART has increased steadily around the world, especially in developed countries, Dr. Michael Chapman of the University of New South Wales and colleagues note in the journal Fertility and Sterility. "The benefits of ART are evident in that almost 1 in 50 births were associated with ART procedures in Australia in 2001," they write.
However, ART has been tied to an increased number of adverse birth outcomes, most notably multiple births and preterm and LBW deliveries
Chapman's team set out to investigate the frequency of premature births following ART pregnancies in Australia, and to identify any maternal characteristics or fertility procedures that might increase the risk.
Their analysis included 17,726 infants born after 15,035 cycles of ART. They compared outcomes to all Australian births for 1999.
Nearly one third of the ART infants were born preterm, and one quarter were LBW, the researchers found. Both preterm birth and LBW were more common in singletons and twins born through ART, and were also more common among nulliparous women (those delivering their first child).
They also observed that preterm birth was 30 percent more likely among infants conceived with fresh compared to frozen embryos, while LBW was 50 percent more common with fresh rather than frozen embryos.
Both LBW and preterm birth were also more common among couples with female-factor infertility compared to male-factor infertility.
The better results seen with frozen embryos may have been due to higher quality embryos being chosen for freezing, the researchers note, as well as the fact that couples having excess embryos available for freezing may have had better-quality eggs to start with.
SOURCE: Fertility and Sterility June 2005.
Copyright © 2005 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
The success rate with frozen embryo transfer (FET) varies widely from program to program and depends on many factors. The more cells present in the embryo and the healthier it appears, the more likely it will survive the freezing and thawing process. About 65-75 percent of healthy-appearing embryos will survive the freezing process.
Although it is called a frozen embryo transfer, we always thaw them and evaluate quality before transfer. Luckily, if the embryos are damaged by the freezing process, it is an all-or-nothing phenomenon -- either the embryo survives or it doesn't. I am not aware of any studies suggesting a higher rate of chromosomally abnormal offspring from transferring surviving frozen embryos as compared to fresh.
The implantation rate per embryo is somewhat lower with frozen embryos when compared to fresh, so we often transfer one more embryo than we might if transferring fresh embryos. We have noted an ongoing pregnancy rate of about 20 percent if three frozen embryos are transferred. Improved laboratory techniques should enable us to grow the embryos in the labs for a longer period before freezing. After four to five days, only the most fit embryos will appear healthy (viable) and will be frozen. As a result, fewer embryos will be frozen, but rates for survival and implantation will be better than with embryos frozen at earlier stages.
Q: Are blasts better to transfer?
A: Day-3 or Blastocyst-stage Embryo Transfer?
Most IVF programs transfer embryos on the third day after fertilization, when embryos usually have reached, what is called, the 6-cell to 8-cell stage. Some investigators have, however, for a number of years been propagating the transfer of embryos on days 5 or 6, when they reach the so-called blastocyst stage.
The longer embryos are cultured in the laboratory, the fewer embryos survive. Longer embryo culture, therefore, is presumed to lead to the survival of the fittest embryos, a process often called natural embryoselection. Proponents of blastocyst-stage embryo
transfer (BCS-ET) have, therefore, argued that BCS-ET will result in higher pregnancy rates per embryo transferred than day-3 transfers and, consequently, allow for high pregnancy rates with even single embryo transfer. Single embryo transfer, in turn, will successfully reduce the high multiple pregnancy rates associated with IVF (see also below).
Q. What are the pros of an open adoption?
A: The Pros of Each Type of Adoption for the Involved Parties are
described in the chart below.
between birth and adoptive families. No identifying
information is provided.
Only nonidentifying information
(e.g., height, hair color, medical history, etc.) is provided
through a third party (e.g., agency or attorney).
Nonidentifying contact is made (via cards, letters, pictures)
through a third party (e.g., agency or attorney).
interaction between birth and adoptive families. Identities
- Provides real choice for birth parents when compared to
- Some feel this provides a sense of closure and ability
to move on with life.
- Allows for some information transfer between birth and
adoptive parents (and perhaps the child).
- Some privacy.
- Increased ability to deal with grief and loss.
- Comfort in knowing child's well-being.
- Sense of control over decision-making in placement.
- Potential for more fully defined role in child's life.
- Potential to develop a healthy relationship with the
child as he or she grows.
- Less pain and guilt about the decision.
- May make the decision to place for adoption easier
(compared to a contested termination of parental rights
- No need to physically share the child with birth
- No danger of birth parent interference or co-parenting.
- Greater sense of control over process.
- Roles may be more clearly defined than in either
confidential or open options.
- Increased sense of entitlement compared to confidential
- Enhanced ability to answer child's questions about his
or her history.
- Increased sense of having the "right" to parent and
increased ability for confident parenting.
- Potential for authentic relationship with the birth
- More understanding of children's history.
- Increased empathy for birth parents.
- Less fear of birth parents reclaiming child because they
know the parent and their wishes.
- Delight of being "chosen" as a parent.
- Protection from unstable or emotionally disturbed birth
|Only true when
relationship is "shared" with the adopted child
- Genetic and birth history known.
- Birthparents are "real" not "fantasy."
- Positive adjustment is promoted in adoptee.
- Direct access to birth parents and history.
- Need to search is eliminated.
- Identity questions are answered (Who do I look like? Why
was I placed?).
- Eases feelings of abandonment.
- Lessening of fantasies: birth parents are "real."
- Increased circle of supportive adults.
- Increased attachment to adoptive family (especially if
the birth parents support the placement).
- Preservation of connections (e.g., with siblings,
- Lessens loyalty conflicts (according to recent
- Exposure to racial and ethnic heritage.
- Ability for evolving, dynamic, and developmentally
appropriate account of the adoption.
Child Welfare Information
Updated on December 7, 2007
|Q. What are the cons of each level of
openness in adoption?
A: The cons of each type of
adoption for the involved parties are listed in the chart
|No contact between birth
and adoptive families. No identifying information is
Only nonidentifying information (e.g.,
height, hair color, medical history, etc.) is provided
through a third party (e.g., agency or attorney).
|Nonidentifying contact is
made (via cards, letters, pictures) through a third party
(e.g., agency or attorney).
||Direct interaction between
birth and adoptive families. Identities are known.
- Less grief resolution due to lack of information
about the child's well-being.
- May encourage denial of fact that child was born and
placed with another family.
- Loss of potential for direct relationship with
adoptive family (and/or child).
- Increased grief in the initial years, less later.
- Loss of contact if intermediary changes or leaves
(i.e., staff turnover, policy changes, or agency
- Birth mother may feel obligated to place child due
to the emotional or financial support given by the
prospective adoptive parents.
- Full responsibility for setting relationship limits
- Potential abuse of trust (fewer safeguards).
- Potential disappointment if adoptive family cannot
meet all expectations or needs.
- Birth mother may feel obligated to place child due
to the emotional or financial support given by the
prospective adoptive parents.
- Allows for denial of "adopted family" or fertility
- Increased fear, less empathy for birth parents.
- No access to additional medical information about
- Less control: agency controls information.
- Loss of the full relationship with the birth
- Lack of ability to have questions answered
- Potentially troubling cards, letters, or pictures.
- Full responsibility for setting relationship limits
- Potential pressure: accept openness or no child.
- Potential difficulty with emotionally disturbed
- Potential for supporting both child and birth
- Possible adolescent identity confusion (unable to
compare physical and emotional traits to their birth
- Limited access to information that others take for
- Potential preoccupation with adoption issues.
- Similar to confidential adoptions, if information
not shared with the adoptee.
- Potential perception that it is unsafe to interact
with birth family directly.
- No clean break for assimilation into family, which
some feel is necessary.
- Potential feelings of rejection if contact stops.
- Difficulty explaining the relationship to peers.
- Potential for playing families against each other.
Information Gateway.Updated on December 7, 2007
with term transparent or transparency interjected Oct 31, 2009
GLOSSARY OF TERMS
DR YORGOS NIKAS / SCIENCE PHOTO LIBRARY
P.O. Box 42841
Cincinnati, Ohio 45242-5020
Hours 9:30 to 4:30 Monday–Friday Eastern Standard Time
Phone: 513-518-7006 Fax: 727-489-2427