GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study

What Was Tested

The trial (not phased) is built around Triptorelin.

The study group will consist of oocyte donors who have GnRHa trigger as a standard trigger concept.

It had three arms (groups): one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Methods A randomized controlled single center study.

All oocyte donors, fulfilling the inclusion criteria, will be eligible for inclusion after randomization.

The first transvaginal ultrasound scan (TVUS) will be performed after seven or eight days after the Elonva depot injection.

Importantly, each patient will be asked to check the presence of an LH surge via a urine LH detection kit at 4 hours after the trigger bolus has been administered.

Who Took Part

Enrollment: 165 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 - 35. BMI \< 28kg/m2. Normal ovarian reserve, defined by AMH \> 1.25 ng/ml or AFC ≥ 6 measured within two months prior to stimulation start. Receiving GnRH-antagonist protocol for ovarian stimulation,. Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: concommitant use of either lh or hmg/ufsh preparations in study cycle.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Triptorelin study did not mask who received what.

It started in 2014-08 with completion listed for 2015-02.

It ran at 1 site in Vietnam.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of mature oocytes (time frame: 30 minutes after oocyte retrieval completed).

It also tracked 2 secondary outcomes, for example Day of bleeding after oocyte pick-up.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Triptorelin in 165 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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