EUCTR2016-004034-14-IT进行中（未招募）1 期
Randomized controlled phase IIb-III clinical trial to assess the effectiveness of different regimens with u-FSH in the infertile male - UFO – UROFOLLITROPIN IN OLIGOZOOSPERMIA
AZIENDA OSPEDALIERA DI PADOVA0 个研究点目标入组 172 人开始时间: 2021年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 172
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Age between 20 and 50 years
- •- Caucasian Ethnicity
- •- Oligozoospermia (total sperm count <39 mil / ejaculate)
- •- Plasma FSH values <8 IU / L
- •- Normal plasma levels of LH and T
- •- Normal female fertility and age <40 years.
- •- Provision of the written informed consent to participation in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 172
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Azoospermia
- •- Endocrine Disorders
- •- Genetic causes of infertility (chromosomal, microdeletions Cr. Y, CFTR mutations)
- •- Varicocele, cryptorchidism, infections, presence of antisperm antibodies, obstruction of the seminal ducts
- •- FSH = 8 IU / L
- •- Hypogonadism
- •- Systemic Diseases, testicular tumors
- •- Known causes of infertility in the partner with obstruction / absence of the tube, endocrine abnormalities, endometriosis, PCOS, oligo-amenorrhea, age = 40 years
研究者
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