Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients

What Was Tested

In this phase 2 trial, researchers set out to test Triptorelin.

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

The primary outcome measure will be the percentage of mature oocytes retrieved.

Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles \>11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence.

Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.

Who Took Part

90 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Age \< 40 years. Anticipated high ovarian response.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: endometriosis \> than grade ii; one ovary.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

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

In this single-blind Triptorelin study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2014-02 with completion listed for 2016-07.

It ran at 2 sites in Greece (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of mature oocytes retrieved (time frame: 36 hours post GnRH agonst administration).

It also tracked 6 secondary outcomes, for example total number of oocytes retrieved, oocyte recovery rate, Fertilization rate, Serum LH, FSH, E2, PRG levels, Duration of luteal phase and OHSS occurrence.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 90 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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