Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients

What Was Tested

In this phase 4 trial, researchers set out to test Triptorelin for pcos.

The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle.

The registry classes the interventions as drug.

More on the Plan

Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian stimulation during IVF treatment.

In contrast to mild OHSS, severe OHSS is a life-threatening complication, characterized by massive ovarian enlargement, ascites, pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena.

COMPARISON: This study aims to compare the development and severity of OHSS, as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix) protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.

Who Took Part

The registry lists 200 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries).

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: normal responders; poor responders.

How the Study Was Run

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

The pcos 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.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2003-11 with completion listed for 2007-05.

It ran at 1 site in Greece.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Development of OHSS. Ongoing pregnancy rate per embryo transfer.

It also tracked 3 secondary outcomes, for example Biochemical pregnancy, Clinical pregnancy and Embryological data.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 200 people with pcos.

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

More context: the Triptorelin compound page, PCOS research.