Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

What Was Tested

The trial (phase 4) is built around Triptorelin.

The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

It had two arms (groups): hCG (active comparator) and hCG and GnRH agonist (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to women only aged up to 38 years.

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

Examples of who could join: Intra-cytoplasmic sperm injection (ICSI) patients below 38 years. 1,2 or 3 rd IVF-cycle.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: polycystic ovary syndrome (pcos) patients; patients with endocrinological diseases or problems.

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.

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

Being open-label, the Triptorelin study did not mask who received what.

It started in 2011-11 with completion listed for 2013-12.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: MII Oocytes (time frame: 3 weeks).

It also tracked 2 secondary outcomes, for example Pregnancy Rate and Patients With Cryopreserved Embryos.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 120 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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