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

ConditionsPoor Ovarian ReserveInfertility (IVF Patients)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Drospirenone drug

    Drug

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

  • Cetrorelix 0.25 mg

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: DrospirenoneExperimental treatment 1 intervention
Group B: cetrorelixActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Metaphase II (Mii) oocytes

Number of mature (MII) oocytes retrieved between drospirenone-PPOS and GnRH antagonist protocols, both using a unified flexible start (leading follicle 14mm), in POR patients undergoing a mandatory freeze-all strategy,

Time frame
Day 0

Secondary outcomes

1

Number of oocytes retrieved

Total numbers

Time frame
Day 0
2

Fertilization rate 2 pronuclei (2PN)

Fertilization rate (2PN) check

Time frame
on day 1
3

Quality of day-3 embryos

Quality of day-3 embryos (gradeing)

Time frame
on day 3
4

LH measure

LH measure to follow premature LH surge (LH \>15 mIU/mL on trigger day) and premature LH rise (LH \>10 mIU/mL)

Time frame
on trigger day ( 2 days before day 0)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ahmed Saad

Lead sponsor

Benha University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: