Hormonal Stimulation of Spermatogenesis
Primary Purpose
Azoospermia, Nonobstructive
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Beta-hCG
Sponsored by
About this trial
This is an interventional treatment trial for Azoospermia, Nonobstructive
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.
Sites / Locations
- Urology department - faculty of medicine, South Valley university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Hormonal therapy Group
L-carnitine Group (Control)
Arm Description
Administration of hormonal therapy (as Beta HCG (5000 IU I.M) twice weekly for three months
Administration of L-carnitine 1000 mg twice daily for three months
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05483621
Brief Title
Hormonal Stimulation of Spermatogenesis
Official Title
Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azoospermia, Nonobstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hormonal therapy Group
Arm Type
Experimental
Arm Description
Administration of hormonal therapy (as Beta HCG (5000 IU I.M) twice weekly for three months
Arm Title
L-carnitine Group (Control)
Arm Type
Other
Arm Description
Administration of L-carnitine 1000 mg twice daily for three months
Intervention Type
Drug
Intervention Name(s)
Beta-hCG
Intervention Description
Treatment of spermatogenesis
Primary Outcome Measure Information:
Title
Hormonal treatment
Description
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Urology department - faculty of medicine, South Valley university
City
Qinā
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Hormonal Stimulation of Spermatogenesis
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