GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian Cyst

What Was Tested

The trial (phase 4) is built around Cetrorelix.

In this study the researchers would like to examine the effect of GnRH antagonist administration at the beginning of the follicular phase in patient presenting with a simple ovarian cyst 25-50 mm.

It had 1 arm (groups): Participants (experimental).

Patients will start GnRH antagonist injections \[Cetrotide (cetrolix) or Orgalutran (ganirelix) - depending on their primary prescription\] for 3-6 days.

The registry classes the interventions as drug.

More on the Plan

Reports on the effect of a baseline ovarian cyst on IVF cycle cancellation and outcome are scare and inconsistent.

A cystic structure of the ovary may be functional or non-functional.

Functional ovarian cysts are usually created by disruption of normal ovulation with the accumulation of intrafollicular fluid.

Hormonal dysfunction prior to ovulation results in expansion of the follicular antrum with serous fluid.

Who Took Part

The registry lists 15 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: inability to provide informed consent; oocyte donor.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Cetrorelix was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-05-01 with completion listed for 2022-03-01.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cyst resolution (time frame: 2 years). Number of oocytes retrieved (time frame: 2 years).

It also tracked 2 secondary outcomes, for example Number of patients which had an oocyte in the aspirated cystic content and Comparison of cycle outcome - oocyte number compared to a previous/future cycle cycle outcome compared to a previous cycle.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Cetrorelix in 15 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, all human trials.