Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF

What Was Tested

This registered phase 4 trial tested Leuprolide for endometriosis.

This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio.

It had four arms (groups): Group 1 (active comparator), Group 2 (experimental), Group 3 (experimental) and Group 4 (active comparator).

Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention.

Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization.

Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 37 actual participants took part.

It was open to women only aged from 21 years up to 42 years.

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

Examples of who could join: Surgical diagnosis of endometriosis. Normal ovarian reserve testing.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: irregular menses; undiagnosed abnormal uterine bleeding; prior adverse reaction to any gnrh agonist.

How the Study Was Run

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

Because people in this Leuprolide 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 endometriosis participants stayed in one arm throughout.

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

It started in 2003-03 with completion listed for 2009-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Patients Who Responded to Controlled Ovarian Hyperstimulation (time frame: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 37 people with endometriosis.

Its size is small, so on its own it can only give an early look.

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

More context: the Leuprolide compound page, Endometriosis research.