History
The first program in the world to specifically recruit women for the purpose of providing eggs for stem cell research.
The BRF Egg Donor Program was initially developed in 2001 by an Ethics Advisory Board led by Professor Ron Green of Dartmouth College (Hastings Center Report, 2002). As the first program in the world to specifically recruit women for the purpose of providing eggs for stem cell research, the Ethics Advisory Board carefully evaluated every step of the process. The primary objective was to ensure that women could donate eggs for research only if the procedure was deemed safe for them.
To maintain donor independence, only women who responded to a newspaper advertisement and had no prior connection to the researchers were eligible. These women underwent thorough psychological and physical assessments, along with a mild hormone stimulation protocol to minimize the risk of hyperstimulation syndromes commonly associated with fertility treatments. Donors had to either reside in or be willing to stay in the greater Boston area for a minimum of two weeks. Between 2001 and 2004, approximately two dozen women participated in the program, with many opting to undergo multiple donation cycles. Compensation is provided for their time, travel, and childcare expenses.
In September 2004, Foundation scientists conducted limited research on human eggs with the aim of deriving stem cells from eggs that had not been fertilized by sperm.
Egg Donor Protocol and Risks
For reference only, BRF currently only accepts eggs and embryos that have already been collected and are no longer needed for fertility treatments.
Donating eggs for stem cell research is similar in many respects to donating eggs for infertility centers. The goal is to stimulate the ovaries to ripen several eggs instead of just one. The greatest risks are over-response to the ovarian stimulation, and adverse response to anesthesia. A brief review of the normal ovarian cycle will clarify the goals and the risks.
Women are born with on the order of one million eggs. They are quiescent in the ovary in a state of arrested development. The onset of menstruation (Day 1) coincides with the lowest levels of steroid hormones in circulation. The pituitary gland in the brain releases hormones that stimulate the ovary to recruit a quiescent, immature egg to grow and finish maturation. The hormones are termed “gonadotropins” because they stimulate the ovary in women and the testis in men.
In response to the pituitary hormones, the ovary synthesizes and releases estrogen into the blood stream, sending a feedback signal to the pituitary. In response to estrogen feedback, the pituitary produces a bolus of gonadotropin on Day 14 that causes the egg to finish its maturation cycle and be released from the ovary into the female reproductive tract.
In order to mature a cohort of 5 to 10 eggs for research purposes, it is necessary to override the natural pituitary stimulation, and to administer higher than normal amounts of gonadotropins. The pituitary can be suppressed by a variety of hormones, including birth control pills and Lupron. Gonadotropins must be administered by subcutaneous injection, analogous to insulin. High amounts of gonadotropins increase the number of eggs collected, and also the risk of “ovarian hyperstimulation syndrome,” a serious potential risk of egg donation.
Uncomfortable side effects of taking Lupron for extended periods of time to suppress other estrogen- responsive conditions, such as uterine fibroids, have been reported by many women. These side effects can be avoided by several approaches, including not using Lupron.
Ovarian hyperstimulation syndrome can be avoided entirely by administering relatively low doses of gonadotropins and carefully measuring the estradiol response in the blood stream. At the first sign of an over response, discontinuing the gonadotropins will eliminate the risk. The long-term risks of taking increased levels of gonadotropins will not be known for another decade or two, but are throught to be low. Risks are further limited by not undergoing more than 2 or 3 cycles of egg collection.
Following about 10 to 12 days of daily gonadotropin injections, eggs are recovered directly from the ovary a few hours before being spontaneously released into the reproductive tract. This is done under anesthesia, usually not “general” anesthesia, but a short-acting anesthesia. One way to avoid adverse reactions to anesthesia is to accept as donors only women with a record of anesthesia exposure with no problems.
The emotional risks of egg donation include hormone-induced depression and the stress of daily injections and frequent trips to the laboratory for hormone measurements and the doctor’s office for ultrasound examinations. The suitability of the donor and her schedule are considered important factors in recruitment.
Donor recruitment includes a full explanation of the science, the risks, the consent form, and a careful assessment that the donor is participating of her own free will out of an interest in moving science forward.
Donating eggs for stem cell research is a serious undertaking, not to be entered into without several months of consideration of all the factors involved.
Copyright © Bedford Research Foundation
GUIDELINES FOR RESEARCH WITH HUMAN EGGS
For reference only, BRF currently only accepts eggs and embryos that have already been collected and are no longer needed for fertility treatments.
- Each and every human egg collected for stem cell research will be handled with respect for its uniqueness and for the effort involved on the part of the donor in contributing her eggs for research.
- Under no circumstances will eggs be exposed to sperm.
- Each egg will be cataloged and accounted for at every step of the procedures. Two members of the research team will sign each notation.
- Eggs will be cultured, manipulated and studied in secure laboratory surroundings. Security measures should include:
- Locked laboratories
- Locked incubators
- Security surveillance systems as necessary to ensure tampering is not possible during the course of the experiments
- Once activated, eggs will not be held in culture for longer than 14 days as intact entities.
- Activated eggs will be allowed to cleave and develop solely in vitro.
- The end-point outcome of each egg will be documented and signed by two members of the research team.
- At the conclusion of each experiment, the investigators will provide the Foundation with a brief statement guaranteeing these guidelines were followed throughout the course of the experiment.
TIME COMMITMENT
For reference only, BRF currently only accepts eggs and embryos that have already been collected and are no longer needed for fertility treatments.
Egg Donors respond to a newspaper ad:
“Research team seeks women aged 21 to 34 with at least one child to donate eggs for stem cell research. Compensation for time, travel and child care. Call 617-623-5670 or write Bedford Research Foundation, PO Box 1028, Bedford, MA 01730”
Altogether, it takes approximately two to three months to complete the intake process, Steps 1 to 6. The process, the science and the risks are discussed thoroughly during the first orientation appointment. Steps 7 through 12 require a two to three week stay in the Boston area.
The steps:
- First orientation appointment, 2 hours
- MMPI written exam, 2 hours
SCL 90, meeting with counselor, 3 hours - Blood testing, 0.5 hours
- Physical exam,1.5 hours
- Meet with study monitor, 2 hours
- Medication instruction, 1 hour
- Baseline bloods, 0.5 hours
- Blood tests x 5 to 6, 0.5 hours
- Ultrasound exams, x 2 to 3, 1.5 hours each
- Egg collection, 4 hours; recovery at home, 12 hours
- Follow-up and SCl-90, meet with counselor, 2 hours
- Follow-up gyn exam, 1.5 hours
Total participation time, approximately 38 to 40 hours, not including travel to each location and child care expenses.
For reference only, BRF currently only accepts eggs and embryos that have already been collected and are no longer needed for fertility treatments.