Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

What Was Tested

This registered phase 4 trial tested Triptorelin.

The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation.

Their hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients.

The registry classes the interventions as drug.

More on the Plan

It seems that a diminished ovarian reserve is the principal factor of poor ovarian response.

Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients.

Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol.

Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.

Who Took Part

Enrollment: 270 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: Regular menstrual cycle. 1 or more failed IVF attempts with poor response. 5 or fewer oocytes retrieved.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: normal responders.

How the Study Was Run

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

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

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

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

It started in 2003-09 with completion listed for 2006-07.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 3 secondary outcomes, for example Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day, Number of mature oocytes retrieved and Number of fertilised oocytes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 270 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.