Hormonal Stimulation of Spermatogenesis

Azoospermia, Nonobstructive Clinical Trial

Official title:

Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483621
• Other study ID #: Abd-Elmo'men
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: October 2023
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Azoospermia
• Azoospermia, Nonobstructive

Intervention

Drug:
• Beta-hCG
Treatment of spermatogenesis

Locations

Country	Name	City	State
Egypt	Urology department - faculty of medicine, South Valley university	Qina

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hormonal treatment	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	from baseline up to 3 months after the treatment day.