Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation

What Was Tested

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

The registry classes the interventions as drug.

More on the Plan

The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF.

The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success.

There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols.

COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.

Who Took Part

Enrollment: 300 planned participants were the target.

It was open to women only aged from 21 years up to 39 years.

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

Examples of who could join: Age 18-39 years. Body mass index 18-29 kg/m2. Menstrual cycle from 24-35 days. Normal basal estradiol (\<80 pg/ml).

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: poor responder patients; polycystic ovaries.

How the Study Was Run

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

Because people in this Triptorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2005-09 with completion listed for 2007-06.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Ongoing pregnancy per embryo transfer.

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

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 300 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.