Hormonal Stimulation of Spermatogenesis

Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia

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, .

Study Overview

• Status: Completed
• Conditions: Azoospermia, Nonobstructive
• Intervention / Treatment: Drug: Beta-hCG

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Qinā, Egypt
    • Urology department - faculty of medicine, South Valley university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Egymedicalpedia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: July 31, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Azoospermia
• Other Study ID Numbers: Abd-Elmo'men

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No