Effectiveness of Testosterone Gel Pretreatment in Poor Responders Undergoing IVF Treatment: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of oocytes
研究概览
简要总结
The main purpose of this study is to compare the number of oocytes retrieved after using transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for 6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization (IVF).
详细描述
A randomized controlled multiple centers study. The study is designed as a superiority trial. The sample size for this trial of 120 subjects in both groups, based upon the primary endpoint of the number of oocytes retrieved.
IVF patients who have failed to conceive and had poor ovarian response (oocytes retrieved ≤ 3) in the last stimulated cycle though using the maximal dose, which is ≥ 300 IU Follicle-stimulating hormone (FSH) or human menopausal gonadotropin (hMG).
Patients will be randomized to use DHEA or testosterone gel as pretreatment. Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of four. Doctors will be blinded to the randomization, but not patients and nurses.
- Study group 1 use 10 mg transdermal testosterone gel per day.
- Study group 2 use 75mg DHEA per day.
Serum testosterone are measured before treatment. Duration of androgen supplement is 6-8 weeks. After completing the pretreatment, patients are asked to come back when they have menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in both groups. Patients will be interviewed for side effects and compliance of treatment.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be eligible for enrolment into this trial, each female subject must fulfill all of the following criteria at the start of enrolment, unless specified otherwise:
- •Had one or two previous failure IVF cycle, using GnRH antagonist protocol (≥ 300 IU FSH/hMG per day) and the number of retrieved oocytes are ≤ 3;
- •Antral follicle counts (AFC) < 6 or Anti-Mullerian Hormone (AMH) < 1.26 ng/ml
排除标准
- •To be eligible for enrolment in this study each subject must not meet any of the following criteria:
- •Oocyte donation cycle
- •Patients have thyroid disease
- •Patients have liver or kidney dysfunction
- •Patients have abnormal puberty or genital development.
- •Patients have previous surgery on ovaries
研究组 & 干预措施
Testosterone gel
Testosterone gel 10mg, used transdermally, once a day. Treatment duration: 6-8 weeks
干预措施: Testosterone gel (Drug)
DHEA
DHEA 25mg tablet, orally, three times per day. Treatment duration: 6-8 weeks
干预措施: DHEA (Drug)
结局指标
主要结局
Number of oocytes
时间窗: 30 minutes after oocyte retrieval completed
Number of oocytes retrieved Number of oocytes retrieved
次要结局
- Clinical pregnancy(7 weeks after embryo transfer)
研究者
Manh Tuong Ho
Doctor
Vietnam National University