Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drospirenone drug, Cetrorelix 0.25 mg.
- Who it may be relevant to
- Registry conditions: Poor Ovarian Reserve, Infertility (IVF Patients). Basic parameters: 20 years — 42 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Drospirenone-Primed Ovarian Stimulation (PPOS) Versus Flexible GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing a Freeze-All Strategy: A Pilot Randomized Controlled Trial
Overview
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
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
- 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
Primary outcome measures
- Metaphase II (Mii) oocytes [Time frame: Day 0]
Secondary outcome measures (8)
- Number of oocytes retrieved [Time frame: Day 0]
- Fertilization rate 2 pronuclei (2PN) [Time frame: on day 1]
- Quality of day-3 embryos [Time frame: on day 3]
- LH measure [Time frame: on trigger day ( 2 days before day 0)]
- Patient burden score [Time frame: Day 0]
- CPR ( clinical pregnancy rate) [Time frame: At 6 wks of pregnancy]
- Cost per cycle [Time frame: at day 0]
- Number of Day 3 embryos [Time frame: Day 3]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Hawaa Fertility Center — Banhā
Identifiers
NCT: NCT07736261 · Hawaa-11