Azoospermia, NonobstructivePhase 1NCT05483621
Hormonal Stimulation of Spermatogenesis
A Phase 1 study testing Beta-hCG in people with Azoospermia, Nonobstructive, run by Egymedicalpedia at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 72 years, men only
- Conditions the study is for
- Azoospermia, Nonobstructive
- What is being tested?
- Beta-hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 72 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with primary infertility due to non-obstructive azoospermia in two seminal analysis
Who cannot join
- Patients with non-obstructive azoospermia with normal or low level of FSH.
- Patients with serum testosterone lower than 3 nmol/L.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology department - faculty of medicine, South Valley university
Qina
About this study
Official title: Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia
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
- Conditions
- Azoospermia, Nonobstructive
- Being tested
- Beta-hCG
- Medical subject headings
- Azoospermia, Nonobstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-hCGDrug
Treatment of spermatogenesis
| Study group | Role | What they receive |
|---|---|---|
| Hormonal therapy Group | Experimental | Administration of hormonal therapy (as Beta HCG (5000 IU I.M) twice weekly for three months Receives: Drug: Beta-hCG |
| L-carnitine Group (Control) | Other | Administration of L-carnitine 1000 mg twice daily for three months Receives: Drug: Beta-hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline up to 3 months after the treatment day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Mar 2021
- Primary completion15 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia, NonobstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483621
- Sponsor's protocol ID
- Abd-Elmo'men
- Status last verified
- Oct 2023
- First submitted
- 31 Jul 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Stimulation of Spermatogenesis in Non-obstructive Azoospermia
- ClinicalTrials.gov ID
- NCT05483621
- Acronym / sponsor ID
- Abd-Elmo'men
- Conditions
- Azoospermia, Nonobstructive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia
| Arm | Type | Receives |
|---|---|---|
| Hormonal therapy Group | Experimental | Drug: Beta-hCGAdministration of hormonal therapy (as Beta HCG (5000 IU I.M) twice weekly for three months |
| L-carnitine Group (Control) | Other | Drug: Beta-hCGAdministration of L-carnitine 1000 mg twice daily for three months |
Who may qualify
- Ages
- 19 to 72 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with primary infertility due to non-obstructive azoospermia in two seminal analysis
Key exclusion criteria (2 listed)
- Patients with non-obstructive azoospermia with normal or low level of FSH.
- Patients with serum testosterone lower than 3 nmol/L.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-hCGTreatment of spermatogenesis | Drug | Hormonal therapy Group, L-carnitine Group (Control) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Beta-hCG in people with Azoospermia, Nonobstructive, run by Egymedicalpedia at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hormonal treatment (time frame: from baseline up to 3 months after the treatment day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.