Clinical trial NCT01443546: Study of Dual Trigger Ovulation in Oocyte Donors
Official title: A Randomized Prospective Trial of Dual Trigger Ovulation in Oocyte Donors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: oocyte donor
oocyte recipient
ovulation trigger
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-09-29
Enrollment: 26
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone.

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 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.

Eligibility 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

Primary outcomes:
measure: Number of Subjects Having Adverse Events
timeFrame: 1 month
measure: Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities
timeFrame: 7 days post retrieval
measure: Ovarian Volume
timeFrame: 7 days post retrieval
Secondary outcomes:
measure: Number of Mature Oocytes Retrieved
timeFrame: 1 day post ovulation
measure: Pregnancies Per Transfer
timeFrame: 4 weeks post retrieval
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College- Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine
state: New York
Study officials:
References: