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Clinical Trials/NCT05483621
NCT05483621
Completed
Phase 1

Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia

Egymedicalpedia1 site in 1 country100 target enrollmentMarch 1, 2021

Overview

Phase
Phase 1
Intervention
Beta-hCG
Conditions
Azoospermia, Nonobstructive
Sponsor
Egymedicalpedia
Enrollment
100
Locations
1
Primary Endpoint
Hormonal treatment
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
March 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Hormonal therapy Group

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

Intervention: Beta-hCG

L-carnitine Group (Control)

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

Intervention: Beta-hCG

Outcomes

Primary Outcomes

Hormonal treatment

Time Frame: 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

Study Sites (1)

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