Current partner codePEPTIDESDE

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

Status

Not yet recruiting

Phase

Phase 1 / Phase 2

Enrollment

100

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

Single-center, open-label, 1:1 parallel-group pilot RCT, stratified by POSEIDON group. Superiority framing is not used - this pilot is not powered for hypothesis testing on efficacy outcomes; those are reported descriptively with 95% confidence intervals. Freeze-all is mandated in both arms by protocol (not patient choice). No patient is offered fresh transfer in either arm, so no patient is excluded for requesting one; this is stated explicitly in the consent process so expectations are set at enrollment. Both arms use a unified flexible start, triggered by leading follicle diameter reaching 14mm - not a fixed calendar day. Rather than fixing both arms to the same stimulation day (which would not account for individual variability in follicular growth rate, a particular concern in POR), both the antagonist and the drospirenone are initiated on the same physiological trigger: once the leading follicle reaches 14mm, whichever arm the patient is randomized to. This achieves genuine unification across arms (identical starting criterion, applied identically) while remaining individualized to each patient's own stimulation pace. This design has direct precedent, as described in Section 2, and retrospective evidence in POR specifically favors flexible-start over fixed-day dosing on oocyte and fertilization outcomes without increased LH-surge risk.

Interventions

Treatment arms and agents.

DRUG

Drospirenone drug

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

DRUG

Cetrorelix 0.25 mg

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

Timeline

From registration to results.

  1. First posted

    Jul 30, 2026

  2. Study start

    Aug 2026

  3. Primary completion

    Oct 2027

  4. Study completion

    Nov 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 30, 2026

Outcomes

What the study measures.

Primary outcomes

Metaphase II (Mii) oocytes

Time frame · Day 0

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,

Secondary outcomes

Number of oocytes retrieved

Time frame · Day 0

Total numbers

Fertilization rate 2 pronuclei (2PN)

Time frame · on day 1

Fertilization rate (2PN) check

Quality of day-3 embryos

Time frame · on day 3

Quality of day-3 embryos (gradeing)

LH measure

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

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

Patient burden score

Time frame · Day 0

Patient-reported treatment burden and satisfaction, measured using the validated Controlled Ovarian Stimulation Impact Measure (COSI; four domains - Interference in Daily Life, Injection Burden, Psychological Health, Compliance Worry), administered at day 0. each patient will give a score from 0-4

CPR ( clinical pregnancy rate)

Time frame · At 6 wks of pregnancy

Clinical pregnancy rate per embryo transfer

Cost per cycle

Time frame · at day 0

Cost per stimulation cycle (drug cost only) in EGP

Number of Day 3 embryos

Time frame · Day 3

Measure the numbers of day 3 embryos

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
42 Years
Sex
FEMALE
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)

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Hawaa Fertility Center

Banhā, Qalyubia Governorate, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

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