Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI

What Was Tested

In this not phased trial, researchers set out to test Cetrorelix.

GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles.

It had two arms (groups): Group (A) (experimental) and group (B) (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis.

It acts on unidentified hypothalamic pulse oscillator neurons.

In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion.

This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary.

Who Took Part

Enrollment: 79 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: All patients should be candidates for ICSI. Age between 20-40 years. Body mass index 18-35 kg/m2. Diagnosis of PCOS according to modified Rotterdam's criteria.

The full record lists 4 inclusion and 1 exclusion criteria.

How the Study Was Run

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

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.

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.

It started in 2023-02-20 with completion listed for 2024-04-20.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cetrorelix in 79 people.

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.