Double Ovarian Stimulation (DuoStim) Comparison of Triggers: Is There Any Advantage Using 3 Different Methods of Trigger for the Second Egg Collection in Predicted Low Responders?
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- number of retrieved oocytes
研究概览
简要总结
This study aims to investigate the efficacy of 3 different trigggers used for final maturation in the second ovarian stimulation in double stimulation protocol (aGnRH and hCG-rec vs. aGnRH only vs. hCG-rec only). The main objective is to compare the number of all retrieved oocytes and mature oocytes in patients predicted to be low ovarian responders.
This is a controlled randomized clinical study where 165 patients will be recruited.
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
- None
入排标准
- 年龄范围
- 28 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI below 32
- •Presence of both ovaries
- •Indication for ovarian stimulation under Double Stimulation protocol (Duo Stim)
- •Meeting the criteria for Duo Stim
- •Medical history, history and physical examination without alterations
- •AMH and AFV results in accordnace to Poseidon classification group 3 or 4 no more than 6 months prior to signing the consent form
- •Ability to participate and comply with the study protocol.
- •To have given written consent
- •Normal karyotype and fragile X.
排除标准
- •Non-compliance with instructions and/or non-formalization of consents or legal requirements for IVF.
- •Concurrent participation in another study
研究组 & 干预措施
a-GnRH
Administration of triptorelin acetate 0.2 mg for final oocyte maturation.
干预措施: Triptorelin acetate (a-GnRH) (Drug)
hCG
Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation.
干预措施: Ovitrelle® (hCG) (Drug)
a-GnRH + hCG
Administration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation.
干预措施: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together (Drug)
结局指标
主要结局
number of retrieved oocytes
时间窗: through study completion, usually will be evaluated on the last day of the treatment
number of oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.
number of mature (MII) oocytes
时间窗: through study completion, usually will be evaluated on the last day of the treatment
number of mature (MII) oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.
次要结局
未报告次要终点
研究者
Andrea Bernabeu García
Co-Director
Instituto Bernabeu