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

Официальное название

Drospirenone-Primed Ovarian Stimulation (PPOS) Versus Flexible GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing a Freeze-All Strategy: A Pilot Randomized Controlled Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Drospirenone drug
  A drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day
• Препарат Cetrorelix 0.25 mg
  Cetrorelix a drug injection daily sc. from 14 mm follicle till hCG trigger day

Первичные конечные точки

• Metaphase II (Mii) oocytes [Срок оценки: Day 0]

Вторичные конечные точки (8)

• Number of oocytes retrieved [Срок оценки: Day 0]
• Fertilization rate 2 pronuclei (2PN) [Срок оценки: on day 1]
• Quality of day-3 embryos [Срок оценки: on day 3]
• LH measure [Срок оценки: on trigger day ( 2 days before day 0)]
• Patient burden score [Срок оценки: Day 0]
• CPR ( clinical pregnancy rate) [Срок оценки: At 6 wks of pregnancy]
• Cost per cycle [Срок оценки: at day 0]
• Number of Day 3 embryos [Срок оценки: Day 3]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Hawaa Fertility Center — Banhā

Идентификаторы

NCT: NCT07736261 · Hawaa-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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