Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 主要终点
- Sperm retrieval rate (SRR)
研究概览
简要总结
Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.
详细描述
Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA, but no RCT are available in the field. This randomized placebo-controlled clinical trial sought to evaluate whether the testicular sperm retrieval rate could result higher in NOA patients treated with follicle-stimulating hormone compared to placebo-treated NOA subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Azoospermia;
- •testis longitudinal axis less than 4.5 cm;
- •serum follicle-stimulating hormone greater than 7.6 IU/L
排除标准
- •History of testicular biopsy,
- •malignancy,
- •varicocele,
- •hyperprolactinemia,
- •thyroid disfunction,
- •chemotherapy,
- •radiotherapy
研究组 & 干预措施
Treated
Urofollitropin 150 IU ampoules three times a week for three months
干预措施: Urofollitropin (Drug)
Controls
Placebo ampoules three times a week for three months
干预措施: Placebo (Other)
结局指标
主要结局
Sperm retrieval rate (SRR)
时间窗: three months
testicular sperm retrieval rate after three months of urofollitropin treatment
次要结局
- IVF pregnancy rate(three to six months)
- IVF implantation rate(three to six months)
研究者
Ettore Caroppo
Dr
Azienda Sanitaria Locale Bari