2023-504188-18-00招募中4 期
Evaluation of the efficacy of micronized natural progesterone (Seidigestan®) vs GnRH antagonists (Astarté®) in the prevention of LH surge during controlled ovarian stimulation: a randomized clinical trial.
Instituto Bernabeu S.L.2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年5月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of oocytes obtained at metaphase II (MII) stage.
研究概览
简要总结
To compare the efficacy (non-inferiority) of the Utrogestan protocol compared to an antagonist protocol.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be eligible to enter the Instituto Bernabeu's oocyte donation program.
- •Age between 18 and 33 years
- •BMI >18 and <30
- •Antral follicle count >8 (adding both ovaries).
- •Presence of both ovaries
- •Ability to participate and comply with the study protocol.
- •Understand Spanish orally and in writing.
- •Have given written consent
排除标准
- •Diagnosis of endometriosis at any stage.
- •Diagnosis of any ovarian tumor whether benign or malignant
- •Concurrent participation in another study
- •Malabsorptive syndromes that may alter the efficacy of Utrogestan ® such as bariatric surgery, ulcerative colitis or Crohn's disease.
- •Irregular periods.
- •Hypogonadotropic hypogonadism.
- •Having received in the previous two months treatment with ovulation stimulators.
- •Having previously participated in the present study.
结局指标
主要结局
Number of oocytes obtained at metaphase II (MII) stage.
Number of oocytes obtained at metaphase II (MII) stage.
次要结局
- Number of cumulus-oocyte complexes (CCO) obtained.
- Number of germinal vesicles (VG).
- Number of metaphase I (MI).
- Number of oocytes suitable for insemination or microinjection.
研究者
María Martínez Moya (Principal Investigator)
Scientific
Instituto Bernabeu S.L.
研究点 (2)
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