Study of Dual Trigger Ovulation in Oocyte Donors

The study population will consist of young women, age 21 to 34, presenting to our facility
with the desire to donate oocytes and who meet FDA and program requirements for donation.

Participants will be randomized to one of the three treatment interventions for triggering
ovulation: 1) a standard dose of hCG, 2) leuprolide acetate 2 mg alone, or 3) a combination
of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).

Study participants who choose to repeat oocyte donation during the course of the study
trial, and who consent to participate in the trial again, will be randomized in a cross-over
manner for any subsequent trials.

Following randomization, the clinical care of study subjects will be the same as for
non-participant oocyte donors. Participants in all three study arms will undergo standard
ovarian stimulation protocol with gonadotropins, standard individualized adjustment of
medication dose, standard criteria for administration of the ovulation trigger dose, and
standard egg retrieval procedure.

The recipient population will be recruited from women, age 18 to 55, who present to our
center wishing to become pregnant using donor oocytes. All prospective participants who meet
the Center for Reproductive Medicine (CRM) criteria be recipients of donated eggs will be
eligible to participate, should they wish to do so.

If a prospective recipient consents to participate in the study, then she would be matched
with either a donor who is not participating in the study (and is receiving one of our
standard triggers for ovulation) or a donor who is participating in the study and whose
medication to trigger ovulation has been randomized into one of three groups: standard dose
hCG, Leuprolide acetate, or a combination of low dose hCG and Leuprolide acetate.

A recipient who chooses to participate in the study will have no additional tests or
procedures over the ones that she would normally do in order to receive donated eggs.

Inclusion Criteria:

Donors

- Young women, age 21 to 34, presenting to our facility with the desire to donate
oocytes and meeting FDA and program requirements for donation.

Recipients

- Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and
meeting FDA and program requirements to be recipients of donated eggs.

Exclusion Criteria:

Donors

- Less than 2 ovaries or any other significant ovarian abnormality

- Does not meet current FDA or program requirements for donation.

- A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)

- A contraindication for the use of oral contraceptive pills (h/o thromboembolism,
breast cancer, undiagnosed vaginal bleeding)

- Known gene defects, genetic abnormalities or abnormal karyotype

- Contraindication or hypersensitivity to any of the concomitant medication prescribed
as part of the treatment regimen in this protocol

- Inability to give informed consent

- Donors who, because of their place of residence or personal situation, would not be
able to commit to all required time points including the one extra visit required by
study participation.

- The subject has a recent history of/or current epilepsy, thrombophilia, diabetes,
cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease