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临床试验/NCT05483621
NCT05483621已完成1 期

Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021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
1 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Hormonal treatment

研究概览

简要总结

Urologists and reproductive specialists are often challenged when facing patients with severe male infertility scenarios. In particular, the treatment of men with NOA demands a deeper insight. In such cases, .

详细描述

The hormonal stimulation of spermatogenesis is still being explored. Thus, there is still little knowledge regarding the type of patient who might benefit from medical treatment, the optimal medication,

the regimen, and the duration of treatment. In male infertility, the induction for treatment with follicle stimulating hormone (FSH) in the induction and maintenance of spermatogenesis in patient with hypogonadotopic hypogonaism. As these patients are normally azoospermic without gonadotropin stimulation and during testosterone therapy

The presence of high numbers of progressively motile and normally formed sperms in the ejaculate during exogenous gonadotropin therapy might result in the desired clinical pregnancy for many infertile couples on an experimental basis and in some places already in clinical routine. FSH preparation are also used for treatment of normogonadotopic infertile men with idiopathic impairment of spermatogemesis.

Pulstile GnRH or exogenous gonadotropins are usually used to induce spermatogenesis and promote testicular enlargement .The regimen for gonadotropin replacement includes an initial use of human chorionic gonadotropin (HCG) for 6 to 12 months and then addition of FSH or human menopausal gonadotropins (HMG) until pregnancy

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 (Participant)

入排标准

年龄范围
19 Years 至 72 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men with primary infertility due to non-obstructive azoospermia in two seminal analysis

排除标准

  • Patients with non-obstructive azoospermia with normal or low level of FSH.
  • Patients with serum testosterone lower than 3 nmol/L.

研究组 & 干预措施

Hormonal therapy Group

Experimental

Administration of hormonal therapy (as Beta HCG (5000 IU I.M) twice weekly for three months

干预措施: Beta-hCG (Drug)

L-carnitine Group (Control)

Other

Administration of L-carnitine 1000 mg twice daily for three months

干预措施: Beta-hCG (Drug)

结局指标

主要结局

Hormonal treatment

时间窗: from baseline up to 3 months after the treatment day.

About 100 participants receiving Beta HCG (5000 IU I.M) twice weekly to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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