Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Cetrorelix for pcos.

It had two arms (groups): Drospirenone (experimental) and cetrorelix (active comparator).

25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day.

The registry classes the interventions as drug.

More on the Plan

At the day of hCG, lab testing will be done in addition to ultrasound assessment by transvaginal probe. the tests are: progesterone, E2, LH.

Assesment will be done for the number quality of follicles and the number quality of embryos developed, development of OHSS, vitrification/thawing of embryos after 1 month then the clinical and chemical pregnancy rate.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to women only aged from 20 years up to 38 years.

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

Examples of who could join: PCOS was diagnosed according to the Rotterdam consensus criteria (two out of three of the following criteria):. Oligo- or anovulation. Clinical and/or biochemical signs of hyperandrogenism. A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinemia and thyroid dysfunction were all rulled out.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: age 38 years; basal fsh level 12 miu/ml; previous ovarian surgery.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

In this single-blind Cetrorelix study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2024-10-01 with completion listed for 2025-01-19.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: number of cases to develop OHSS (time frame: 1 week). number of embryos (time frame: 5 days).

It also tracked 1 secondary outcome, for example clinical pregnancy rate.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Cetrorelix in 50 people with pcos.

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

More context: the Cetrorelix compound page, PCOS research.