The Effect of Pre-treatment With GnRH Analogues Prior in Vitro Fertilization in Patients With Endometriosis

What Was Tested

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

It had two arms (groups): GnRHa (active comparator) and Physiological serum (placebo comparator).

Physiological serum subcutaneous injection with same delivery device and same volume that active comparator ) administered on days 1, 28 and 56 after menstrual cycle.

The registry classes the interventions as drug.

More on the Plan

Endometriosis is defined as the presence of ectopic endometrial tissue which induces a local inflammatory reaction.

Usually, this tissue is located at any level in the pelvic region, but extrapelvic locations have been described.

It is a chronic disease whose cause is unknown, although a genetic predisposition has been proven.

Assisted reproduction techniques (ART) are the treatment of many causes of infertility, including endometriosis.

Who Took Part

Enrollment: 200 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: BMI \< 28 Kg/m2. Age \< 40 years old. Signed informed consent to perform IVF and participation in this study.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: other relevant disease that contraindicates a pregnancy.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The endometriosis 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.

Blinding on both sides kept the endometriosis participants and researchers unaware of who received Triptorelin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2012-03 with completion listed for 2015-03.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clinical pregnancy rate by started cycle (time frame: 2 weeks after biochemical diagnosis of pregnancy).

It also tracked 10 secondary outcomes, for example Number of oocytes retrieved, total and metaphase II, Embryo quality, Number and size of endometrioma(s), Rate of pregnancy to term in patients with endometriosis / endometriomas, Miscarriage rate and Rate of healthy and live births.

What This Means in Plain Language

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, Endometriosis research.