← Human Trials & Peer-Reviewed Studies
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.