Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation

What Was Tested

This registered phase 4 trial tested hCG (human chorionic gonadotropin) and Leuprolide for endometriosis.

The purpose of this study is to compare gene expression profiles in endometrial biopsies during the window of implantation after triggers of oocyte maturation using GnRH agonist or hCG and compared with their natural cycles in order to identify genes that may be dysregulated in GnRH agonist-triggered cycles.

The investigators also intend to evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

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

Induction of oocyte maturation with GnRH agonist.

Induction of oocyte maturation with hCG.

The registry classes the interventions as drug.

More on the Plan

Unfortunately, some studies, but not all, have also reported lower pregnancy rates in these cycles as compared to cycles using hCG trigger and this has been attributed to possible impaired endometrial receptivity.

The investigators intend to obtain endometrial biopsies collected from the same subject in a natural cycle and then a biopsy during either a GnRH agonist or hCG triggered stimulation.

Expression profiles of mRNAs will first be screened using microarray technology.

Relative levels of specific mRNAs that display altered expression in the GnRH-triggered samples, as assayed by microarray, will then be confirmed by real-time, quantitative reverse transcription/polymerase chain reaction (Q-PCR).

Who Took Part

The registry lists 7 actual participants took part.

It was open to women only aged from 21 years up to 33 years.

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

Examples of who could join: Ages between 21 and 33. Normal baseline serum FSH \< 10mIU/mL.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: hypothalamic dysfunction; baseline serum fsh ≥ 10miu/ml.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The endometriosis participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

In this single-blind hCG (human chorionic gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2012-04 with completion listed for 2014-12.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Endometrial Gene Expression Profile (time frame: 7 days after trigger of oocyte maturation).

It also tracked 1 secondary outcome, for example Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) and Leuprolide in 7 people with endometriosis.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the hCG (human chorionic gonadotropin) compound page and the Leuprolide compound page, Endometriosis research.