Study of Dual Trigger Ovulation in Oocyte Donors
Stopped early · Phase 4
Conditions studied: Infertility
In brief
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.
Key facts
- Study ID
- NCT01443546
- Run by
- Weill Medical College of Cornell University
- People needed
- 26
- Starts
- 2013-01-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2019-06-26
Who can join
Age: 21 and older, up to 55. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Weill Cornell Medical College- Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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