Study of Dual Trigger Ovulation in Oocyte Donors

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The project is a randomized, controlled, prospective study of oocyte donors comparing the safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Leuprolide

Criteria

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