Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Women undergoing IVF/ICSI who are candidates for a GnRH-antagonist protocol are randomly assigned 1:1 to oral linzagolix or the standard injectable GnRH antagonist (ganirelix or cetrorelix). A third, non-randomized group of women with a clinical indication for progestin-primed ovarian stimulation (PPOS) - for example, a need for a freeze-all strategy - is enrolled concurrently as a comparator cohort. The randomized comparison (linzagolix vs. injectable antagonist) is the primary, non-inferiority analysis; the PPOS cohort provides an exploratory, non-randomized comparison, analyzed with adjustment for baseline differences.
調査の概要
状態
詳細な説明
This is a single-center, prospective, randomized, controlled non-inferiority trial with a concurrent non-randomized comparator cohort, conducted at CENTRO AMBRA. Women eligible for a GnRH-antagonist protocol are randomized 1:1 to oral linzagolix or the injectable GnRH antagonist using a computer-generated permuted-block randomization sequence (block size of 4, no stratification); allocation is concealed until treatment initiation. A separate, concurrent cohort of women with a clinical indication for PPOS is enrolled as a non-randomized comparator; because assignment to this cohort reflects clinical criteria, it may differ systematically from the randomized arms - confounding by indication limited to the PPOS comparison. This is addressed through pre-specified multivariable adjustment and, where sample size permits, propensity-score methods; the PPOS comparison is interpreted as an association, the randomized comparison as supporting non-inferiority. As treatment is known to investigators and patients, there is no masking (open-label); oocyte and embryo assessment follows standardized, predefined procedures. A target of 40 participants per group (120 total) was defined based on the pre-specified non-inferiority margin of 2.0 MII oocytes. All participants undergo a routine clinical follow-up visit 5 days after oocyte pick-up."
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Female, aged 18 to 42 years
- Indication for IVF/ICSI with controlled ovarian stimulation at CENTRO AMBRA
- Population unselected for ovarian reserve (normal, poor, and high responders are eligible)
- Written informed consent, including consent for off-label use of linzagolix and for data processing
- For the two antagonist arms (Linzagolix and Injectable GnRH Antagonist): acceptance of randomization
Exclusion Criteria:
- Known contraindications or hypersensitivity to the study drugs
- Uterine pathology relevant to the study outcome (e.g., uterine malformations, significant submucosal fibroids)
- Contraindications to pregnancy or to ovarian stimulation
- Concurrent participation in another interfering interventional study
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：A - Linzagolix
|
Description: Linzagolix Type: Drug Group: A Description: Linzagolix 200 mg administered orally once daily, started per center protocol (fixed stimulation day or upon appearance of the dominant follicle) and continued through the day of trigger. Investigational off-label use for suppression of the premature LH surge during controlled ovarian stimulation. |
|
アクティブコンパレータ：B - Injectable GnRH Antagonist (Ganirelix/Cetrorelix)
|
Ganirelix Type: Drug Group: B Description: Ganirelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation. Cetrorelix Type: Drug Arm: B Description: Cetrorelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation. |
|
アクティブコンパレータ：C - PPOS (Progestin-Primed Ovarian Stimulation) Cohort
|
This is a non-randomized, concurrently enrolled comparator cohort (not part of the 1:1 randomization). Medroxyprogesterone Acetate - Type: Drug - Arm: C - Description: Medroxyprogesterone acetate 10 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy. Micronized Progesterone - Type: Drug - Arm: C - Description: Micronized progesterone 100-200 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy. |
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 |
|---|---|---|
|
Number of Mature (MII) Oocytes Retrieved
時間枠：At oocyte retrieval, approximately 36 hours after trigger (first study cycle)
|
Number of metaphase II (mature) oocytes collected at oocyte retrieval. Non-inferiority of linzagolix versus the injectable GnRH antagonist will be concluded if the lower bound of the 95% confidence interval for the adjusted mean difference in MII oocytes (adjusted for ovarian reserve, age, BMI, gonadotropin type and dose, and trigger type) excludes a loss greater than the pre-specified non-inferiority margin of 2.0 MII oocytes. An exploratory comparison with the PPOS cohort is also performed, adjusted for baseline confounders. |
At oocyte retrieval, approximately 36 hours after trigger (first study cycle)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of Premature LH Rise
時間枠：From initiation of LH-suppressive treatment to the day of trigger (up to approximately 12 days)
|
From initiation of LH-suppressive treatment to the day of trigger (up to approximately 12 days)
|
協力者と研究者
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- LINZA-COS
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
米国で製造され、米国から輸出された製品。
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