Hormonal Stimulation of Spermatogenesis

Phase 1

Completed

• Conditions: Azoospermia, Nonobstructive
• Interventions: Drug: Beta-hCG

• Registration Number: NCT05483621
• Lead Sponsor: Egymedicalpedia

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

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-02-15
• Study Completion: 2022-03-01
• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-07-31
• Study First Posted: 2022-08-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hormonal therapy Group	Beta-hCG	Administration of hormonal therapy (as Beta HCG (5000 IU I.M) twice weekly for three months
L-carnitine Group (Control)	Beta-hCG	Administration of L-carnitine 1000 mg twice daily for three months

Primary Outcome Measures

Name	Time	Method
Hormonal treatment	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

Trial Locations

Locations (1)

Urology department - faculty of medicine, South Valley university; 🇪🇬 Qinā, Egypt