Endometrial Receptivity After GnRH Agonist Triggering

What Was Tested

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

If gonadotropin-releasing hormone agonist (GnRHa) are used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.

By testing different luteal support protocols on women undergoing GnRHa triggering, the investigators aim to find out which protocol resembles the most the gene expression profile observed after hCG triggering and conventional luteal phase support, in order to choose it as the most adequate in terms of endometrium receptivity and safety (OHSS incidence).

It had six arms (groups): hCG (active comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 35 actual participants took part.

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

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

Examples of who could join: Healthy oocyte donor women. Aged 18-35 years. With a menstrual cycle length of 26-35 days. Normal ultrasound scan of uterus and ovaries. Normal basal hormones.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: subjects with current or previous history of an endocrine abnormality; subjects with an abnormal outcome of blood biochemistry or hematology; subjects with an abnormal cervical smear.

How the Study Was Run

Design: randomized, factorial 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.

Only one side, usually the endometriosis participants, was kept unaware of whether hCG (human chorionic gonadotropin) was given.

Those kept unaware of assignments: investigator.

It started in 2011-11 with completion listed for 2012-05.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: endometrial receptivity gene expression profile (time frame: participants will be followed for the duration of the cycle, an expected average of 4 weeks).

It also tracked 1 secondary outcome, for example Incidence of moderate/severe OHSS in all different treatment group.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) and Triptorelin in 35 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 hCG (human chorionic gonadotropin) compound page and the Triptorelin compound page, Endometriosis research.