Hormonal Stimulation of Spermatogenesis

NCT ID: NCT05483621

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-03-01

Brief Summary

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, .

Detailed Description

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

Conditions

Azoospermia, Nonobstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hormonal therapy Group

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

Group Type: EXPERIMENTAL

Beta-hCG

Intervention Type: DRUG

Treatment of spermatogenesis

L-carnitine Group (Control)

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

Group Type: OTHER

Beta-hCG

Intervention Type: DRUG

Treatment of spermatogenesis

Interventions

Beta-hCG

Treatment of spermatogenesis

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. Patients with non-obstructive azoospermia with normal or low level of FSH.

2. Patients with serum testosterone lower than 3 nmol/L.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Urology department - faculty of medicine, South Valley university

Qina, , Egypt

Countries

Egypt

Other Identifiers

Abd-Elmo'men

Identifier Type: -

Identifier Source: org_study_id