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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Ahmed S Saad, phD
- 電話番号：020 +201221709989
- メール：drahmedsaad@live.com
研究連絡先のバックアップ
- 名前：Walid A Abdel Halim, phD
- 電話番号：020 0201228343376
- メール：waleedabdellateef@gmail.com
研究場所
-
-
Qalyubia Governorate
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Banhā、Qalyubia Governorate、エジプト、13512
- Hawaa Fertility Center
-
コンタクト：
- Ahmed s saad, phD
- 電話番号：020 01221709989
- メール：drahmedsaad@live.com
-
コンタクト：
- walid a abdelateef, phD
- 電話番号：020 0201100434632
- メール：waleedabdelateef@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Drospirenone
50 cases will receive drospirenone in the form of 1 tablet / d when the leading follicle reaches 14 mm till hCG trigger day
|
A drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day
|
|
アクティブコンパレータ：cetrorelix
50 cases will receive cetrorelix when the leading follicle reaches 14 mm till hCG trigger day
|
Cetrorelix a drug injection daily sc.
from 14 mm follicle till hCG trigger day
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Metaphase II (Mii) oocytes
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of oocytes retrieved
時間枠：Day 0
|
Total numbers
|
Day 0
|
|
Fertilization rate 2 pronuclei (2PN)
時間枠：on day 1
|
Fertilization rate (2PN) check
|
on day 1
|
|
Quality of day-3 embryos
時間枠：on day 3
|
Quality of day-3 embryos (gradeing)
|
on day 3
|
|
LH measure
時間枠：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
時間枠：Day 0
|
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
|
Day 0
|
|
CPR ( clinical pregnancy rate)
時間枠：At 6 wks of pregnancy
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Clinical pregnancy rate per embryo transfer
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At 6 wks of pregnancy
|
|
Cost per cycle
時間枠：at day 0
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Cost per stimulation cycle (drug cost only) in EGP
|
at day 0
|
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Number of Day 3 embryos
時間枠：Day 3
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Measure the numbers of day 3 embryos
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Day 3
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Ahmed s Saad, phD、Professor of OB & GYN
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Hawaa-11
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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