2024-510596-37-00撤回4 期
Transdermal testosterone pretreatment in poor responders with androgen receptor polymorphism undergoing ICSI: A Randomized Clinical Investigation.
Instituto Bernabeu S.L.4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月29日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- number of oocyte cumulus complexes obtained
研究概览
简要总结
To determine whether pretreatment with transdermal testosterone increases the number of cumulus-oocyte complexes (COCs) obtained after ovarian stimulation by more than 1.5 in patients with low ovarian reserve and androgen receptor polymorphism undergoing intracytoplasmic sperm injection (ICSI).
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 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with low ovarian reserve according to Bologna criteria: at least two of the following three: ○ Age equal to or greater than 40 years. ○ Previous cycle with less than 4 oocytes retrieved. ○ Low ovarian reserve markers (antral follicle count <5-7; AMH <0.5-1.1 ng).
- •Muestra seminal procedente de eyaculado.
- •Ability to comply with the study protocol.
- •To have given their written consent.
- •Carriers of the androgen receptor polymorphism: between 22 and 24 CAG repeats.
- •Body Mass Index (BMI) less than
- •Indication for in vitro fertilization.
- •Presence of both ovaries.
- •Absence of ovarian cysts.
- •Absence of endometriosis.
- •Karyotype and normal fragile X study.
- •Absence of severe male factor.
排除标准
- •Non-compliance with instructions or non-formalization of informed consent.
- •Concurrent participation in another study.
结局指标
主要结局
number of oocyte cumulus complexes obtained
number of oocyte cumulus complexes obtained
次要结局
- Number of metaphase II stage oocytes obtained.
- Duration of stimulation (days)
- Dose of medication used
- Fertilization rate
- Blastocyst formation rate
- Cancellation rate
- Viable intrauterine gestation (confirmed by ultrasound)
研究者
Ana Fuentes Rozalen
Scientific
Instituto Bernabeu S.L.
研究点 (4)
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