Hormonal Stimulation of Spermatogenesis

Sponsor

Egymedicalpedia (Industry)

Overall Status

Completed

CT.gov ID

NCT05483621

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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, .

Condition or Disease	Intervention/Treatment	Phase
Azoospermia, Nonobstructive	Drug: Beta-hCG	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermiato evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Feb 15, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hormonal therapy Group Administration of hormonal therapy (as Beta HCG (5000 IU I.M) twice weekly for three months	Drug: Beta-hCG Treatment of spermatogenesis
Other: L-carnitine Group (Control) Administration of L-carnitine 1000 mg twice daily for three months	Drug: Beta-hCG Treatment of spermatogenesis

Arm

Intervention/Treatment

Experimental: Hormonal therapy Group

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

Drug: Beta-hCG

Treatment of spermatogenesis

Other: L-carnitine Group (Control)

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

Drug: Beta-hCG

Treatment of spermatogenesis

Outcome Measures

Primary Outcome Measures

Hormonal treatment [from baseline up to 3 months after the treatment day.]
To evaluate the outcome of hormonal therapy for men with non-obstructive azoospermia

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 72 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology department - faculty of medicine, South Valley university	Qinā		Egypt

Sponsors and Collaborators

Egymedicalpedia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Egymedicalpedia

ClinicalTrials.gov Identifier:

NCT05483621

Other Study ID Numbers:

Abd-Elmo'men

First Posted:

Aug 2, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Azoospermia

Study Results

No Results Posted as of Aug 2, 2022