Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI (PPOS)
Drospirenone-Primed Ovarian Stimulation (PPOS) Versus Flexible GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing a Freeze-All Strategy: A Pilot Randomized Controlled Trial
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Ahmed S Saad, phD
- 电话号码：020 +201221709989
- 邮箱：drahmedsaad@live.com
研究联系人备份
- 姓名：Walid A Abdel Halim, phD
- 电话号码：020 0201228343376
- 邮箱：waleedabdellateef@gmail.com
学习地点
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Qalyubia Governorate
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Banhā、Qalyubia Governorate、埃及、13512
- Hawaa Fertility Center
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接触：
- Ahmed s saad, phD
- 电话号码：020 01221709989
- 邮箱：drahmedsaad@live.com
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接触：
- walid a abdelateef, phD
- 电话号码：020 0201100434632
- 邮箱：waleedabdelateef@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Drospirenone
50 cases will receive drospirenone in the form of 1 tablet / d when the leading follicle reaches 14 mm till hCG trigger day
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A drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day
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有源比较器：cetrorelix
50 cases will receive cetrorelix when the leading follicle reaches 14 mm till hCG trigger day
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Cetrorelix a drug injection daily sc.
from 14 mm follicle till hCG trigger day
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Metaphase II (Mii) oocytes
大体时间：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,
|
Day 0
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of oocytes retrieved
大体时间：Day 0
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Total numbers
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Day 0
|
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Fertilization rate 2 pronuclei (2PN)
大体时间：on day 1
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Fertilization rate (2PN) check
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on day 1
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Quality of day-3 embryos
大体时间：on day 3
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Quality of day-3 embryos (gradeing)
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on day 3
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LH measure
大体时间：on trigger day ( 2 days before day 0)
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LH measure to follow premature LH surge (LH >15 mIU/mL on trigger day) and premature LH rise (LH >10 mIU/mL)
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on trigger day ( 2 days before day 0)
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Patient burden score
大体时间：Day 0
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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
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Day 0
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CPR ( clinical pregnancy rate)
大体时间：At 6 wks of pregnancy
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Clinical pregnancy rate per embryo transfer
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At 6 wks of pregnancy
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Cost per cycle
大体时间：at day 0
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Cost per stimulation cycle (drug cost only) in EGP
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at day 0
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Number of Day 3 embryos
大体时间：Day 3
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Measure the numbers of day 3 embryos
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Day 3
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合作者和调查者
赞助
调查人员
- 研究主任：Ahmed s Saad, phD、Professor of OB & GYN
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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