Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- ovarian response
研究概览
简要总结
The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.
详细描述
Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients.
There is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes
排除标准
- •FSH > 12
- •Previous ovarian surgery
研究组 & 干预措施
Testosterone and FSHr
干预措施: testosterone and FSHr alone (Drug)
testosterone and FSHr-LHr
干预措施: Testosterone and FSHr-LHr (Drug)
结局指标
主要结局
ovarian response
时间窗: within 2 weeks after begining ovarian stimulation
number of oocytes obtained per ovarian stimulation cycle
次要结局
- clinical pregnancy rate(within 5 weeks (plus or minus 1 week) after embryo transfer)
- Implantation rate(within 5 weeks (plus/minus 1 week) after embryo transfer)
- Live birth rate(within 9 months (plus/minus 1 month) after embryo transfer)