Over the past several decades, considerable effort has been expended toward the successful
cryopreservation of various human cells. While attempts at cryopreservation have been
directed at different tissue types, one of the most vigorously pursued targets has been
reproductive tissue. Historically, cryopreservation of human sperm has existed for several
decades. The earliest reports of pregnancies (Trounson et al., 1983) and births (Zeilmaker
et al., 1984) from the cryopreservation of human embryos occurred in the early 1980s.
Presently, the freezing and storage of human embryos following in vitro fertilization (IVF)
is standard practice at most fertility clinics. In 2003, the CDC Assisted Reproductive
Technology success rates report stated that 4,246 live births occurred out of 17,517
non-donor frozen embryo cycles. . Because the human egg is a relatively voluminous cell
with abundant cytoplasm, crystallization at the time of freezing may result in damage to the
organelles. Secondly, a mature metaphase II oocyte contains a fragile spindle apparatus
involved in cleavage.
The purpose of this research study is to evaluate a method of freezing and thawing oocytes.
This evaluation will be made by comparing the survival rates and rates of fertilization,
cleavage and embryo quality of fresh oocytes and frozen-thawed oocytes which will be
inseminated during the IVF (in vitro fertilization) treatment cycle. In addition, the same
comparisons will be made between frozen oocytes from infertile women and those of egg
donors. You are being asked to be in this study because you are currently undergoing in
To be eligible for inclusion into this study, each subject must satisfy the following
1. Infertile woman wishing to conceive and whose physician has recommended that she
2. Participants must be aged 21 to 35 years
3. Body mass index (BMI) < 38.
4. Serum results for cycle day 3 FSH <10 mIU/ml.
5. Must have male partner whose semen analysis meets the clinic criteria for ICSI. Use
of donor sperm is also acceptable.
6. Be willing and able to comply with the protocol for the duration of the study.
7. Have voluntarily provided written informed consent under WIRB, prior to any
study-related procedure that is not part of normal medical care, with the
understanding that the subjects may withdraw consent before they start Lupron without
prejudice to their future medical care.
A patient may NOT be entered into the study if she presents with ANY of the following
1. Clinically significant systemic disease.
2. Known endometriosis Grade III - IV (ASRM classification).
3. Any previous cycle indicating a low response to gonadotropin stimulation (defined as
retrieval of < 10 eggs at retrieval)
4. Three or more previous ART cycles without a clinical pregnancy
5. Abnormal, undiagnosed, gynecological bleeding.
6. Previous ovarian surgery
7. Known allergy or hypersensitivity to recombinant gonadotropin preparations or any
other study-related medications.
8. Known current substance abuse.
9. Simultaneous participation in another clinical trial.
10. Current smoker.
11. An extrauterine pregnancy within the last 3 months before OCP treatment commences.
12. Previous participation in similar study at different centers.