NCT03939390已完成4 期
Conventional Stimulation in Follicular Phase vs. Luteal Phase Stimulation in Patients With Suboptimal Response. Randomized Clinical Trial. SUBLUTEAL Study
Instituto Bernabeu1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年1月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- number of oocytes
研究概览
简要总结
This study aims to investigate the difference in the number of oocytes obtained by performing ovarian stimulation in follicular phase vs. luteal phase in a population of patients with previous suboptimal response.
This is a controlled randomized clinical study.
We aim to include 41 patients diagnosed with suboptimal response who will undergo an ovarian stimulation in order to vitrify and accumulate oocytes.
The main variable for evaluating the efficacy in this exploratory study will be the number of oocyte cumulus complexes obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meets Bologna criteria to be diagnosed as poor responder
- •Less than 10 oocytes obtained in a prior controlled protocol of conventional ovarian stimulation
- •Age < 41 years
- •Body Mass Index (BMI) between 18 and 32 kg/m2
- •Regular menstrual cycles between 21 and 35 days.
- •Indication for in vitro fertilization
- •Indication to start stimulation with 150mcg of corifollitropin alpha
- •Presence of both ovaries
- •Ability to participate and comply with study protocol
- •Signing an informed consent form
排除标准
- •Presence of follicles larger than 10 mm in the randomization visit
- •Endometriosis stage III/IV
- •Patients with less than 4 oocytes in previous ovarian stimulation and poor ovarian reserve parameters (as per Bologna criteria)
- •Concurrent participation in another study
研究组 & 干预措施
luteal phase stimulation
Experimental
干预措施: time of administration of Corifollitropin Alfa (Drug)
结局指标
主要结局
number of oocytes
时间窗: at the end of stimulation
number of oocytes after ovarian stimulation
次要结局
未报告次要终点
研究者
Jorge Sunol Sala
Dr
Instituto Bernabeu
研究点 (1)
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