Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

What Was Tested

This registered not phased trial tested Triptorelin for endometriosis.

(A single centre randomised controlled trial).

It had two arms (groups): oral oestroprogestogen pre-treatment (active comparator) and gonadotropin-releasing hormone (GnRH) pre-treatment (experimental).

Preparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle.

Preparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle.

The registry classes the interventions as drug.

Who Took Part

The registry lists 166 planned participants were the target.

It was open to women only aged from 18 years up to 39 years.

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

Examples of who could join: Histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy. Only first three ART cycles. Normal uterine cavity. Eligible for ovarian stimulation with long agonist protocol.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: presence of large intramural fibroids (\> 3 cm); \<4 oocytes obtained in any previous fresh art cycle; ART with sperm derived from testicular biopsy.

How the Study Was Run

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

The endometriosis participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

The Triptorelin group and the comparison group ran side by side rather than switching.

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

It started in 2013-06 with completion listed for 2017-12.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): clinical pregnancy rate per initiated ART cycle.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Triptorelin in 166 people with endometriosis.

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

More context: the Triptorelin compound page, Endometriosis research.