Drospirenone-Primed Ovarian Stimulation (PPOS) Versus Flexible GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing a Freeze-All Strategy: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Metaphase II (Mii) oocytes
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
stastician
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Metaphase II (Mii) oocytes
时间窗: 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,
次要结局
- Number of oocytes retrieved(Day 0)
- Fertilization rate 2 pronuclei (2PN)(on day 1)
- Quality of day-3 embryos(on day 3)
- LH measure(on trigger day ( 2 days before day 0))
- Patient burden score(Day 0)
- CPR ( clinical pregnancy rate)(At 6 wks of pregnancy)
- Cost per cycle(at day 0)
- Number of Day 3 embryos(Day 3)
研究者
Ahmed Saad
Professor of OB & GYN
Benha University