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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
A drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day
Cetrorelix a drug injection daily sc. from 14 mm follicle till hCG trigger day
Hawaa Fertility Center
Banhā, Qalyubia Governorate, Egypt
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
Number of oocytes retrieved
Total numbers
Time frame: Day 0
Fertilization rate 2 pronuclei (2PN)
Fertilization rate (2PN) check
Time frame: on day 1
Quality of day-3 embryos
Quality of day-3 embryos (gradeing)
Time frame: on day 3
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)
Patient burden score
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
Time frame: Day 0
CPR ( clinical pregnancy rate)
Clinical pregnancy rate per embryo transfer
Time frame: At 6 wks of pregnancy
Cost per cycle
Cost per stimulation cycle (drug cost only) in EGP
Time frame: at day 0
Number of Day 3 embryos
Measure the numbers of day 3 embryos
Time frame: Day 3
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