Study of Dual Trigger Ovulation in Oocyte Donors

What Was Tested

This registered phase 4 trial tested Leuprolide.

It had three arms (groups): hCG (active comparator), Lupron Trigger (active comparator) and Dual Trigger (experimental).

Lupron and hCG combined ovulation trigger.

The registry classes the interventions as drug.

More on the Plan

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

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.

The recipient population will be recruited from women, age 18 to 55, who present to their center wishing to become pregnant using donor oocytes.

Who Took Part

26 actual participants took part.

It was open to women only aged from 21 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Young women, age 21 to 34, presenting to their facility with the desire to donate oocytes and meeting FDA and program requirements for donation. Women, age 21 to 55, presenting to their facility with the desire to donate oocytes and meeting FDA and program requirements to be recipients of donated eggs.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: does not meet current fda or program requirements for donation; 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2013-01 with completion listed for 2016-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Subjects Having Adverse Events (time frame: 1 month). Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities (time frame: 7 days post retrieval). Ovarian Volume (time frame: 7 days post retrieval).

It also tracked 2 secondary outcomes, for example Number of Mature Oocytes Retrieved and Pregnancies Per Transfer.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 26 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.