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Progesterone Primed Protocol Versus GnRH Antagonist in With PCO Undergoing ICSI

Plain-language guide to NCT05951400: phase 2, phase 3 randomized trial of Cetrorelix, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05951400
Phase
phase 2, phase 3
Status
completed
Start
2024-01-01
Completion (planned or actual)
2026-03-30
Participants
200 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
IVF; PCO
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2, phase 3 trial tested Cetrorelix.

It had two arms (groups): Dydrogestrone (experimental) and GnRH antagonist (active comparator).

The registry classes the interventions as drug.

More on the Plan

Each patient will be subjected to: Full history taking.

Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.

Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.

Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle.

Who Took Part

200 actual participants took part.

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: Undergoing trial of ICSI. BMI ≤ 30. AFC ≥ 20.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: any known contraindications to the approved fertility drugs; severe endometriosis; uterine malformations or abnormal uterine cavity.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Cetrorelix and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Cetrorelix study did not mask who received what.

It started in 2024-01-01 with completion listed for 2026-03-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: oocytes retrieved (time frame: 1 month of induction for ICSI trial).

It also tracked 2 secondary outcomes, for example Duration of stimulation days and chemical pregnancy rate.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cetrorelix in 200 people.

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

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

Our Notes on the Compound

Cetrorelix: An FDA-approved GnRH antagonist used in IVF to prevent a premature LH surge.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.