Hormonal Stimulation of Spermatogenesis

Study Overview
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Brief Summary
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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
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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

Official Title
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Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia

Conditions
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Azoospermia, Nonobstructive

Intervention / Treatment
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* Drug: Beta-hCG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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. |