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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age20-42
SponsorAhmed Saad

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Contraindication to ovarian stimulation

Known müllerian anomaly

Uncontrolled systemic disease

5 prior failed IVF attempts

Trial design

Treatments tested in this trial

  • Drospirenone drug
  • Cetrorelix 0.25 mg

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ahmed Saad

Lead sponsor

Benha University

Sponsor institution