Status:
TERMINATED
Study of Dual Trigger Ovulation in Oocyte Donors
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Infertility
Eligibility:
FEMALE
21-55 years
Phase:
PHASE4
Brief 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 hC...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01443546
Start Date
January 1 2013
End Date
June 1 2016
Last Update
June 26 2019
Active Locations (1)
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1
Weill Cornell Medical College- Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine
New York, New York, United States, 10021