2025-525005-20-00招募中4 期
A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Recombinant Human Follicle Stimulating Hormone (r-hFSH-alfa originator) and Human Chorionic Gonadotropin (hCG) in Enhancing Sperm Concentration in Men with Oligozoospermia, Low Testosterone, and Normal FSH Serum Levels (APHRODITE Group 3): A Collaborative Research Initiative
Martin-Luther-Universitaet Halle-Wittenberg7 个研究点 分布在 3 个国家目标入组 138 人开始时间: 2026年2月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 7
研究概览
简要总结
To assess the impact of the combined administration of r-hFSH-alfa originator plus hCG compared to no treatment on sperm concentration in men with lowered semen analysis, low testosterone serum levels and normai FSH serum levels.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male with an age ≥ 18 years old ≤ 55 years old
- •BMI < 35 kg/m2
- •Male infertility of at least 12 months (ICMART definition)
- •Sperm concentration ≥ 1 million/ml and ≤ 16 million/ml at screening
- •Normal FSH serum levels (1.5-8 IU/mL) at screening
- •Normal LH serum levels (at least 1.5 IU/ml) at screening
- •Low testosterone serum levels (between 210 and 350 ng/dL, corresponding to 7.3-12.1nmol/L) at screening
- •Normal serum prolactin and thyroid-stimulating hormone (TSH) values as measured in a local lab
- •Have not received gonadotropin, aromatase inhibitors and SERMs at least 3 months before the start of screening
- •No clinically significant abnormal findings in the screening haematology, biochemistry, and urinalysis parameters
排除标准
- •Diagnosed genetic mutations responsible for abnormal sperm concentration (e.g., YCMD, CFTR gene mutations)
- •Signs of testicular inflammation and or infection, as well as signs of obstruction (including testicular volume higher than 25 mL at ultrasound examination)
- •Patients with clinical varicocele (any grade)
- •At Screening and during the study period the presence of an uncontrolled chronic disease (ongoing acute episodes or inadequate treatments), such as diabetes mellitus, thyroid disorders, autoimmune diseases such as arthritis, vasculitis or inflammatory bowel disease
- •Presence of active malignancies
- •Patients with history of gonadotoxic treatments
- •Patients that received testosterone therapy at any time during the previous 12 months of the study screening
- •Patients with a history of anabolic steroid use
- •Patients with one testis
研究组 & 干预措施
GONASI HP 250 U.I. / 1 ml polvere e solvente per soluzione iniettabile
Test
干预措施: GONASI HP 250 U.I. / 1 ml polvere e solvente per soluzione iniettabile (Drug)
GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen
Test
干预措施: GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen (Drug)
研究者
Center for Reproductive Medicine and Andrology
Scientific
Martin-Luther-Universitaet Halle-Wittenberg
研究点 (7)
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