Hormonal Stimulation of Spermatogenesis

Egymedicalpedia

Status and phase: Completed; Phase 1

Conditions: Azoospermia, Nonobstructive

Treatments: Drug: Beta-hCG

Study type: Interventional

Funder types: Industry

Identifiers

NCT05483621

Abd-Elmo'men

Details and patient eligibility

About

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, .

Full 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

Enrollment: 100 patients

Sex: Male

Ages: 19 to 72 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Hormonal therapy Group

Experimental group

Description:

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

Treatment:

Drug: Beta-hCG

L-carnitine Group (Control)

Other group

Description:

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

Treatment:

Drug: Beta-hCG