Fertility Centers of Illinois has expanded the options for couples wishing to conceive by use of a “third-party” candidate. These services are now offered by the Center for Collaborative Reproduction (CCR), and encompass the management of all cycles that utilize fresh egg donation, frozen banked eggs, sperm donation, gestational carrier and embryo donation.
All of these cases commonly include additional high-risk screening and blood tests (much that is mandated by the FDA), informed consent, and psychological/legal counseling beyond that which normally occurs when couples conceive either spontaneously or by the use of assisted reproductive technologies (ART), but use their own gametes.
The Centers for Disease Control (CDC) does a national assessment of ART rates throughout the country, including egg donor results. This national summary for 2012 is currently under initial review and will be published in the very near future.
However, the preliminary reports suggest that egg donor rates have increased somewhat as compared to 2011. The published results for 2011 indicate that 10,797 fresh donor cycles were performed throughout the US and this resulted in a 64.7 percent pregnancy rate per transfer, with a 54.8 percent live birth rate. Another 7,733 frozen donor cycles were performed with a 45.5 percent pregnancy rate per transfer and a 35.7 percent live birth rate.
The FCI egg donor rates for both 2011 and 2012 have been consistently comparable to the national summary. However, the 2013 preliminary rates for egg donation at FCI, for our in-house donor program, have exceeded national rates. At Fertility Centers of Illinois, our donors are thoroughly screened for infectious diseases (per the FDA), and genetic diseases, and also for their fertility, all prior to acceptance into our program.
In 2013, 57 in-house egg donor cycles were performed with a 77 percent clinical pregnancy rate per transfer and a current 68 percent ongoing pregnancy rate. Live birth outcomes are still pending. These rates actually exceed the 2011 and 2012 national results, where fresh donor eggs were retrieved and fertilized on the day of egg retrieval, and the resulting embryos transferred to the recipient parents either fresh, or having been previously frozen and thawed.
Our in-house egg donor program, strives to provide compassionate care to our patients and egg donors throughout their journey. Fertility Centers of Illinois is invested to make every effort to accommodate the egg donor candidate and recipient patient needs throughout the match and in vitro fertilization (IVF) process.
Our egg donors have continued care at FCI, even after their egg retrieval, to ensure their health is optimal and to allow future recipients an opportunity to have the most updated and medically screened donor candidate. We understand that each donor match is unique. Therefore, case by case, FCI will accommodate recipient requests for varying degrees of openness, for future medical information sharing between the donor and recipient or child.
The newest technology to emerge in the field of egg donation is the freezing of eggs prior to fertilization. Fertility Centers of Illinois’ first cycles utilizing frozen eggs, as part of Donor Egg Bank USA (DEBU), were performed in 2012. We are now a member of a consortium of clinics throughout the US, and as a part of DEBU freezes and stores donor eggs in our own laboratory, which are designated for the egg bank. The egg bank as a whole reports a 50 percent clinical pregnancy rate per transfer for 2013, with an ongoing pregnancy rate of 44 percent.
As a member of DEBU, our patients have access to donor eggs from all across the country, and a greater and more diverse choice of donors than ever before. The advantage of the egg bank for donors is largely one of convenience. That is, the donor may cycle and be retrieved without having to be specifically matched and coordinated with the cycle of a prospective recipient, and without any potential reduction in compensation.
The guidelines for donor compensation have been published by the ASRM several years ago, and been long adhered to by Fertility Centers of Illinois. However, in 2013, Fertility and Sterility published a guideline for egg donation that speaks specifically to recipients of advanced age. These guidelines have evolved from a growing set of data on egg donation which has been accumulated over the past decade or so.
Advanced maternal age is clearly one of the most common indications for egg donation, along with premature ovarian failure, and gonadal dysgenesis. Even when women are healthy going into pregnancy, those women nearing the age of 50 appear to have higher rates of pregnancy induced hypertension, gestational diabetes, and caesarian delivery, as compared to a similarly healthy, but younger, counterpart.
Multiple gestation increases risks in all age groups, but were found to be particularly increased in women over 55 years of age. Thus, the ASRM advocates that egg donation only be performed in healthy advanced maternal age women who have passed additional medical screening. Every effort should be made to limit multiple gestations and providing either donor eggs or embryos to women over 55 years of age, even when having no underlying medical problems, should be discouraged.
In 2013, ASRM published revised guidelines for sperm donation that incorporate recent information about optimal screening and testing for sexually transmitted diseases, genetic diseases and psychological assessment. The goal of this donor screening is to minimize the risk to recipients of donor sperm.
To this end, ASRM guidelines and FDA US regulations state that the sperm donor, as well as the recipient and her male partner, undergo testing for sexually transmitted diseases. In addition, the recipient shall undergo testing for blood type, an antibody screen, and rubella and varicella titers.
All of donor sperm inseminations at Fertility Centers of Illinois utilize commercial, reputable sperm banks from across the United States and adhere to FDA US regulation for screening and testing of donors. ASRM guidelines for sperm donation provide a lengthy list of potential high risk factors for donors who should not be accepted based on medical history alone including, for example, men who have tested positive for West Nile Virus.
The 2013 ASRM guidelines outline screening of known/directed donors as well. These potential donors should be generally healthy overall and agreeable to the same FDA regulatory risk factor questionnaire and the same sexually transmitted diseases and genetic screening that an anonymous sperm donor would undergo. Known/directed donors who test reactive, however, or demonstrate a high risk factor for a relevant communicable disease may not be prohibited from use according to current FDA US regulation.
Provided that the sperm sample is labeled to indicate any associated risk increase, the medical practice has a policy/procedure in place that speaks to that exact test result/risk, and the recipient of tissue using the sample has been informed of the donor results/risks. It is further recommended that donor sperm samples be frozen and quarantined prior to their use, as outlined in the document. It is the opinion of ASRM that use of fresh semen can only be justified for sexually intimate couples.
Since our previous letter of 2011, ASRM has published guidelines for practices that utilize gestational carriers. These guidelines describe the appropriate screening and testing of genetic parents and gestational carriers to most effectively reduce the possibility of complications, and to address the complex medical and psychosocial issues that may involve the gestational surrogate, the intended parents, and the children.
ASRM specifically suggests that these guidelines pertain only to such cases that take place within the United States, and that these guidelines provide minimal FDA standards for care. State by state, other requirements and/or restrictions my already exist that must also be taken into account. In general, the parties that are primarily involved include the genetic or intended parents who will ultimately have responsibility of raising the child, and the gestational carriers.
The intended parents (gamete sources), whether male and female or of same gender, should undergo FDA US regulatory screening and testing requirements in the same manner as anonymous gamete donors. This includes the FDA high risk screening for communicable diseases, as well as specific blood and urine testing. For gestational carriers, ASRM recommends testing of all carriers and their partners for infectious diseases and possible uterine factors, but no FDA regulations apply to the carrier of embryos.
ASRM also sets forth criteria for who may be considered an appropriate gestational carrier. These recommendations suggest that carriers should be between the ages of 21 and 45, and should have had at least one term, uncomplicated pregnancy previously and actively parenting a child. Ideally, the carrier should not have had more than five previous deliveries, and not more than three previous caesarean sections.
Many of the IVF clinics throughout the US have witnessed an increased accumulation of cryopreserved embryos being stored. Couples who have become pregnant and do not desire future pregnancy, or have other reasons for declining to transfer their embryos may now donate theses excess embryos to another couple. New guidelines for embryo donation were recently published by the ASRM in 2013.
This document also discusses the FDA regulations (eligibility or exemptions possible) of a donor embryo as determined by the status of gametes at the time of embryo creation, and not of the embryos themselves. Cryopreserved embryos, created from anonymous oocyte or sperm donation, require that the oocyte donor must have met all of the FDA US regulatory high risk screening and communicable disease testing (donor eligibility determination must be met at the time of tissue recovery). Embryos resulting from sexually intimate couples, initially created from their own autologous use, meet the FDA regulation exemption.
Although, there is still medical review and documentation by the medical facility to confirm the embryo exemption per the FDA regulations: A cryopreserved embryo, originally exempt that is intended for directed or anonymous donation, when possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient.
The FDA “retro” high risk screening and communicable disease tests can only begin after 180 days from the time embryos were originally cryopreserved. The recipient of these FDA exempt embryos must be informed of their risks, prior to embryo transfer.
The Center for Collaborative Reproduction is comprised of a dedicated team of clinicians and coordinators who are specially trained in the management of these complex cycles utilizing egg donors, sperm donors, gestational carriers and embryo donation. The team also includes a committed psychological staff that counsels Fertility Centers of Illinois intended-parents and the third party candidates involved (donors and gestational carriers). The team works closely with legal experts in the Chicagoland area that deal only with reproductive contracts.
The options for family building have expanded and so has our team, our 2014 goal is the creation of a donor sibling registry. There will be much more to come in the future.