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Clinical Trials in Egypt / NCT07736261
Starting soon Phase 1/2

Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI

NCT07736261 · tracked via the Priya Life Science Egypt tracker
Sponsor
Ahmed Saad
Phase
Phase 1/2
Started
2026-08
Last updated
2026-07-30

Condition(s) studied

Poor Ovarian ReserveInfertility (IVF Patients)

Investigational drug(s) / intervention(s)

Drospirenone drugCetrorelix 0.25 mg

Drospirenone drug: A drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day

Cetrorelix 0.25 mg: Cetrorelix a drug injection daily sc. from 14 mm follicle till hCG trigger day

Study summary

Participants will:

* Take either drospirenone (a daily pill) or the standard daily injection during their ovarian stimulation cycle, alongside their regular fertility hormone injections
* Undergo egg retrieval, with all resulting embryos frozen (no fresh embryo transfer in this study)
* Have a frozen embryo transferred in a later cycle
* Complete two short questionnaires about their treatment experience - once before starting the injections/pills, and once after the stimulation phase ends
* Be followed to determine if the embryo transfer results in a pregnancy

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
42 Years
Healthy volunteers
No
Inclusion Criteria: * Spontaneous menstrual cycles (21-35 days) * Poor ovarian response per Bologna criteria (≥2 of 3): advanced age ≥40 or risk factor for POR; previous poor response (≤3 oocytes with conventional stimulation); abnormal ovarian reserve (AFC \<7 or AMH \<1.1 ng/mL) * POSEIDON group recorded at enrollment (1-4) for stratified randomization and pre-specified subgroup description - corrects a known limitation of Bologna-only classification, which pools biologically distinct POR phenotypes * Indication for IVF/ICSI * Willing and able to undergo mandatory freeze-all/FET protocol * Signed informed consent, including explicit acknowledgment that fresh transfer is not offered in either study arm Exclusion Criteria: * Contraindication to ovarian stimulation * Known müllerian anomaly * Uncontrolled systemic disease * 5 prior failed IVF attempts * Known contraindication to drospirenone (per product labeling, e.g., renal impairment, adrenal insufficiency, conditions predisposing to hyperkalemia)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hawaa Fertility Center Banhā Qalyubia Governorate

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07736261 on ClinicalTrials.gov ↗ ← All trials in Egypt