GnRH Antagonist Versus GnRH Agonist in Polycystic Ovary Syndrome During in Vitro Fertilization - Embryo Transfer

What Was Tested

This registered phase 3 trial tested Triptorelin and Cetrorelix.

GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been accomplished by several randomized controlled trials compared with conventional GnRH agonist long protocol in polycystic ovary syndrome (PCOS) patients.

Moreover, there are debating issues that refer to the timing of GnRH antagonist initiation.

The purpose of this study is to investigate the laboratory and clinical priority during ovarian stimulation for IVF in patients with PCOS treated with three different protocols.

It had three arms (groups): GnRH antagonist, SD #1 starting group (experimental), GnRH antagonist, SD #6 starting group (experimental) and Conventional GnRH agonist long group (active comparator).

Start GnRH antagonist from stimulation day 1 during ovulation induction cycles.

Start GnRH antagonist from stimulation day 6 during ovulation induction cycles.

Conventional GnRH agonist long protocol.

The registry classes the interventions as drug.

More on the Plan

GnRH Antagonist is Started on Stimulation Day 1 GnRH Antagonist is Started on Stimulation Day 6 Conventional GnRH Agonist Long Protocol.

Who Took Part

The registry lists 43 actual participants took part.

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: PCOS patients (diagnosed as 2003 ASRM(The American Society for Reproductive Medicine)/ESHRE(The European Society of Human Reproduction and Embryology) consensus meeting guideline). Age 20-40 years. Patients who have normal uterus.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: patients who have abnormal thyroid function; patients who have abnormal prolactin test; patients who have diabetes, or cushing's syndrome, or congenital adrenal hyperplasia, or androgen-producing tumor.

How the Study Was Run

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

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

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

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

It started in 2011-06 with completion listed for 2016-12-31.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): number of oocyte retrieved.

It also tracked 1 secondary outcome, for example pregnancy rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin and Cetrorelix in 43 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 and the Cetrorelix compound page, all human trials.