Male InfertilityPhase 4NCT02275169
FSH in Azoospermic Men
A Phase 4 study testing Follicle Stimulating Hormone in people with Male Infertility, run by Azienda Sanitaria Locale Bari.
Trial summary
This study was designed in 2015, but since funds were not obtained, the study was not performed. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Follicle Stimulating Hormone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2019
- Phase
- Phase 4
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male infertility defined as failure to conceive following 12 months of unprotected intercourse
- Non-obstructive azoospermia confirmed after extended sperm search in the pellet in two consecutive samples
- Normal testosterone level Exclusion criteria
- Obstructive azoospermia
- Hypogonadotropic hypogonadism
- Low testosterone levels
- Hyperprolactinemia
- Adrenal dysfunctions
Who cannot join
None listed.
About this study
Official title: FSH Treatment in Patients With Non-obstructive Azoospermia
This study was designed in 2015, but since funds were not obtained, the study was not performed.
- Conditions
- Male Infertility
- Being tested
- Follicle Stimulating Hormone
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicle Stimulating HormoneDrug
150 UI three times a week
| Study group | Role | What they receive |
|---|---|---|
| Follicle stimulating hormone | Experimental | Not described Receives: Drug: Follicle Stimulating Hormone |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful sperm recovery
Presence or not of sperm in the ejaculate or surgical recovery or not of testicular sperm
Measured: three months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startFeb 2015 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: study funds not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ettore Caroppo, Azienda Sanitaria Locale Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275169
- Sponsor's protocol ID
- 1111
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2014
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FSH Treatment in Patients With Non-obstructive Azoospermia
- ClinicalTrials.gov ID
- NCT02275169
- Acronym / sponsor ID
- 1111
- Conditions
- Male Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study funds not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale BariUniversity, hospital or other
- Study start
- Feb 2015 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- 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.
This study was designed in 2015, but since funds were not obtained, the study was not performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follicle stimulating hormone | Experimental | Drug: Follicle Stimulating Hormone |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male infertility defined as failure to conceive following 12 months of unprotected intercourse
- Non-obstructive azoospermia confirmed after extended sperm search in the pellet in two consecutive samples
- Normal testosterone level Exclusion criteria
- Obstructive azoospermia
- Hypogonadotropic hypogonadism
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Follicle Stimulating Hormone150 UI three times a week | Drug | Follicle stimulating hormone |
Primary outcome
Successful sperm recovery
Time frame: three months after treatment
Presence or not of sperm in the ejaculate or surgical recovery or not of testicular sperm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Related trials for Male Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Follicle Stimulating Hormone in people with Male Infertility, run by Azienda Sanitaria Locale Bari.
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 8 inclusion and 0 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: withdrawn, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Successful sperm recovery (time frame: three months after treatment). 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 29 Oct 2026.