NCT06698263尚未招募4 期
13-cis Retinoic Acid (Isotretinoin) and Sperm Production
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Millions of Sperm Per Ejaculate
研究概览
简要总结
This study aims to evaluate the effectiveness of weekly administration of isotretinoin (40 mg) in increasing sperm production in men with oligozoospermia, a condition characterized by a low sperm count. Participants will be randomized into two groups: one receiving isotretinoin and the other a placebo. The primary outcome will be the change in sperm production over 20 weeks 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite >1 year of unprotected intercourse).
- •Abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week.
- •Male patients aged 21-55 years
- •Affiliation with a social security system
- •Ability to provide informed consent
排除标准
- •-Men participating in another clinical trial
- •Clinically significant abnormal findings at screening
- •Known genetic infertility (e.g. Klinefelter syndrome or Y-chromosome microdeletions),
- •Hypogonadotropic hypogonadism (that might respond to gonadotropin injections),
- •Severe mental health problems requiring medications
- •Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
- •History of psychiatric disorders (e.g., depression, suicidal tendencies).
- •Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction.
- •Men currently receiving tetracycline containing medications
- •Men who have used isotretinoin within eight weeks of the start of dosing
- •Men with elevated serum triglycerides
研究组 & 干预措施
Isotretinoin
Experimental
Isotretinoin (40 mg) orally, once per week for 20 weeks
干预措施: Isotretinoin (Drug)
control group
Placebo Comparator
Placebo identical in appearance and administration schedule.
干预措施: Control group (placebo) (Drug)
结局指标
主要结局
Millions of Sperm Per Ejaculate
时间窗: Months 24
Concentration calculation of Millions of sperm per ejaculate in men treated with 13-cis retinoic acid
次要结局
未报告次要终点
研究者
研究点 (1)
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