Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

What Was Tested

This registered phase 4 trial tested HMG (Human Menopausal Gonadotropin) for endometriosis.

In addition to the histological findings, by analysing the correlation of the morphological pattern and gene expression profile of human endometrium on the day of oocyte retrieval in patients of both treatment groups, the investigators want to study the implantation potential.

It had two arms (groups): Recombinant FSH (active comparator) and human chorionic gonadotropin (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to women only aged from 18 years up to 36 years.

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

Examples of who could join: \< 36 years on day of randomisation. FSH \< 12 in the early follicular phase. Normal ultrasound scan. BMI between 18 and 29 (both inclusive). Randomisation at outpatient clinic.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: endometriosis ≥ grade 3; PCO syndrome; poor responder.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got HMG (Human Menopausal Gonadotropin) and who got the comparison, which limits bias.

The HMG (Human Menopausal Gonadotropin) group and the comparison group ran side by side rather than switching.

In this single-blind HMG (Human Menopausal Gonadotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2009-01 with completion listed for 2009-11.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): number of oocytes (time frame: 2 weeks after start of the treatment).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of HMG (Human Menopausal Gonadotropin) in 30 people with endometriosis.

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

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

More context: the HMG (Human Menopausal Gonadotropin) compound page, Endometriosis research.