Elagolix for Fertility Enhancement Clinical Trial

What Was Tested

This registered phase 2 trial tested Elagolix (non-peptide) for endometriosis.

It had two arms (groups): Elagolix (experimental) and Oral contraceptives (Ortho Cyclen) (active comparator).

Elagolix will be compared to a less potent standard commonly used prior to IVF or embryo transfer, namely estrogen containing birth control pills.

The registry classes the interventions as drug.

More on the Plan

Elagolix (Orilissa) is a new generation FDA approved orally active GnRHr antagonist that is rapidly reversible, for the treatment of endometriosis and pelvic pain.

In this multi-central randomized controlled trial (RCT), the EFFECT Trial, the investigators plan to recruit 100 subjects with prior unexplained IVF failure with positive endometrial BCL6/SIRT1 expression.

To qualify all subjects will need to have a preimplantation genetic testing (PGT-A) tested euploid embryo and intentions to undergo frozen embryo transfer.

Primary study outcomes will be pregnancy outcome.

Who Took Part

The registry lists 10 actual participants took part.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Anti-Mullerian Hormone (AMH) \> 0.5 and \< 10. At least 1 euploid embryo for transfer. Prior endometrial biopsy showing elevated BCL6 and SIRT1 expression. Endometrial thickness \> 5.9 and \< 14 mm.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: uterine fibroids \> 4 cm (intramural); polycystic ovary syndrome (rotterdam criteria); ovarian failure and donor eggs or oocytes.

How the Study Was Run

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

Because people in this Elagolix (non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Elagolix (non-peptide) group and the comparison group ran side by side rather than switching.

Being open-label, the Elagolix (non-peptide) study did not mask who received what.

It started in 2022-01-15 with completion listed for 2023-08-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Live Births (time frame: Month 9).

It also tracked 2 secondary outcomes, for example Number of Miscarriages and Number of Viable Pregnancies.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Elagolix (non-peptide) in 10 people with endometriosis.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Elagolix (non-peptide) compound page, Endometriosis research.