Evaluation of the Efficacy of Micronized Natural Progesterone (Seidigestan®) Vs GnRH Antagonist (Astarté®) in the Prevention of LH Peak During Controlled Ovarian Stimulation: a Randomized Clinical Trial.
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
- 1
- 主要终点
- MII oocytes
研究概览
简要总结
This study aims to investigate if the use of oral micronized natural progesterone is not inferior to the use of subcutaneous antagonist in preventing LH peak in controlled ovarian stimulation.
详细描述
The study will aim to include 150 women (egg donors): 75 per group and the principal variable will be the number of retrieved mature (MII) oocytes. Randomized, prospective, controlled, single center, phase IV study.
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
- 18 Years 至 33 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligibility for the oocyte donation program at Instituto Bernabeu.
- •Age between 18 and 33 years
- •BMI >18 and <30
- •Overall antral follicle count >8
- •Presence of both ovaries
- •Ability to participate and comply with the study protocol
- •Oral and written comprehension of Spanish
- •Having given written consent
排除标准
- •Endometriosis at any stage
- •Any ovarian tumor whether benign or malignant
- •Concurrent participation in another study
- •Malabsorptive syndromes that may alter the efficacy of Seidigestan ® 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
研究组 & 干预措施
CONTROL GROUP
The patient will start to administer: (1) daily subcutaneous injections of gonadotropins on day 1 of ovarian stimulation (2) daily subcutenous injections of ganirelix ("antagonist") on day 5 or 6 of ovarian stimulation. Both medication will be stopped 1-2 days before egg retrieval.
干预措施: Ganirelix Acetate (Drug)
STUDY GROUP
The patient will start to administer: (1) daily subcutaneous injections of gonadotropins on day 1 of ovarian stimulation (2) daily oral capsules of natural micronized progesterone on day 1 of ovarian stimulation. Both medication will be stopped 1-2 days before egg retrieval.
干预措施: Progesterone 200 MG (Drug)
结局指标
主要结局
MII oocytes
时间窗: Egg collection day (between 8 and 14 days after starting of ovarian stimulation)
number of mature (MII) oocytes in both stimulations.
次要结局
- Duration(Egg collection day (between 8 and 14 days after starting of ovarian stimulation))
研究者
Maria Martinez Moya
Principal Investigator
Instituto Bernabeu