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CompletedNCT05483621Updated Oct 19, 2023

Hormonal Stimulation of Spermatogenesis

A Phase 1 interventional study of Beta-hCG in Azoospermia, Nonobstructive, sponsored by Egymedicalpedia. Completed at 1 site in Egypt. Open to male participants aged 19 Years to 72 Years. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by Egymedicalpedia · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Mar 2021, registered Jul 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
19 Years to 72 Years
Sex
Male
01

Study 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, .

Read the 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

02

Conditions studied

  • Azoospermia, Nonobstructive
03

In context

Azoospermia, Nonobstructive

23 studies on the registry are indexed under Azoospermia, Nonobstructive; 7 are open to participants now.

This study's enrollment of 100 is above the median of 61 across 12 interventional studies indexed under Azoospermia, Nonobstructive.

Browse Azoospermia, Nonobstructive studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 72 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Hormonal therapy Group

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

    Drug: Beta-hCG

  • Other
    L-carnitine Group (Control)

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

    Drug: Beta-hCG

Interventions

  • DrugBeta-hCG

    Treatment of spermatogenesis

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: from baseline up to 3 months after the treatment day.

07

Study locations

1 site
  • Urology department - faculty of medicine, South Valley university
    Qinā, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05483621
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
Aug 2, 2022
Start date
Mar 1, 2021
Primary completion
Feb 15, 2022
Completion
Mar 1, 2022
Last update
Oct 19, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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