EXpression PRofile Endometrium Samples Study

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin) for endometriosis.

This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®.

Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known.

It had two arms (groups): Gonal-f® + Ovitrelle® + Long Agonist Protocol (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a pilot open-label, national, multi-centre, Phase IV trial.

This trial will be conducted with outpatients.

Once subject has met all eligibility criteria, she will be treated with Gonal-f® prefilled pen and will receive on a randomization basis the GnRH agonist or antagonist.

Ultrasound scans (US) will be performed concomitantly with hormonal assessment at each visit.

Who Took Part

The registry lists 27 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

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

Examples of who could join: Infertile female or infertile male. Infertile female means diverse infertility etiologies including tubal disease (excepting hydrosalpinx) and so called "unexplained infertility". Suitable for ART: IVF undergoing first or second attempt, ICSI undergoing first attempt. 18-35 years old, body mass index (BMI) less than or equal to 27 kilogram per square meter (kg/m\^2), non smoking. No history of active genito-urinary infection. Normal thyroid function (or adequate substitution for at least 3 months).

The full record lists 11 inclusion and 15 exclusion criteria; among the exclusions: subjects with ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term; subjects with uterine malformation, diethylstilbestrol syndrome, adenomyosis, synechia; subjects with history of previous ohss.

How the Study Was Run

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

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the endometriosis participants and staff both knew the treatment.

It started in 2008-08 with completion listed for 2010-08.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® (time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®). Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® (time frame: Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®).

It also tracked 7 secondary outcomes, for example Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer, Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol, Gene Expression in Participants Without Blastocyst Transfer, Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer, Gene Expression in Participants With Good or Poor Response to Gonal-f® and Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f®.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 27 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, Endometriosis research.