OligoasthenoteratozoospermiaPhase 4NCT07862725
Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
A Phase 4 study testing Antioxidants + Clomiphene Citrate, Antioxidants + FSH and Antioxidants Alone in people with Oligoasthenoteratozoospermia and Male Infertility, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
This prospective randomized controlled trial will compare three treatment approaches for men with idiopathic oligoasthenoteratozoospermia (OAT), a condition characterized by abnormalities in sperm count, movement, and shape without an identified cause. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men only
- Conditions the study is for
- Oligoasthenoteratozoospermia, Male Infertility
- What is being tested?
- Antioxidants + Clomiphene Citrate, Antioxidants + FSH and Antioxidants Alone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteQatar
- Study dates
- 15 Oct 2026to 15 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 21 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged 21 to 50 years
- Diagnosed with idiopathic oligoasthenoteratozoospermia
- Sperm concentration ≥2 million/mL on at least one semen analysis
- FSH <8.0 IU/L
- Normal serum testosterone
- Normal karyotypeAbsence of Y-chromosome microdeletions
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- No varicocele or clinically insignificant Grade I varicocele only
- Ability and willingness to comply with the study protocol and follow-up schedule
- Provision of written informed consent.
Who cannot join
- History of cryptorchidism.
- Previous orchidopexy.
- Previous testicular torsion.
- Previous testicular trauma.
- History of chemotherapy.
- History of radiotherapy.
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- Previous testicular surgery.
- Azoospermia.
- Severe oligospermia with sperm concentration <2 million/mL.
- Known genetic abnormalities, including Klinefelter syndrome.
- Y-chromosome microdeletion.
- Hormonal treatment for infertility within the previous 6 months.
- Current use of medications known to affect spermatogenesis, including testosterone or anabolic steroids.
- Significant medical comorbidities such as liver failure, renal disease, or uncontrolled diabetes. History of varicocelectomy within the previous year.
- Pyospermia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Nadir Ibrahim Fadol contact
Qatar1 site
Ambulatory Care Center (ACC), Hamad Medical Corporation
Doha, Baladiyat ad Dawhah, 3050
Sara Taha Shabana, 55398571 ext. 00974, sshabana@hamad.qa
Haitham El Bardisi
About this study
This prospective randomized controlled trial will compare three treatment approaches for men with idiopathic oligoasthenoteratozoospermia (OAT), a condition characterized by abnormalities in sperm count, movement, and shape without an identified cause. Participants will be randomly assigned in a 1:1:1 ratio to receive antioxidant therapy alone, antioxidant therapy plus clomiphene citrate, or antioxidant therapy plus follicle-stimulating hormone (FSH) for 6 months.
The study will evaluate whether adding clomiphene citrate or FSH to antioxidant therapy improves semen parameters compared with antioxidant therapy alone. The main outcomes will include changes in sperm concentration, motility, and morphology. The study will also assess sperm function, hormonal changes, treatment adherence, and adverse events.
- Conditions
- Oligoasthenoteratozoospermia, Male Infertility
- Being tested
- Antioxidants + Clomiphene Citrate, Antioxidants + FSH, Antioxidants Alone
- Keywords
- Idiopathic infertility, Oligoasthenoteratozoospermi, Selective estrogen receptor modulators, FSH, Antioxidants, Clomiphene citrate
- Medical subject headings
- Oligospermia, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidants + Clomiphene CitrateDrug
Also called Clomiphene Citrate, Antioxidants
Participants will receive the same antioxidant regimen as the active comparator arm plus clomiphene citrate 50 mg orally every other day for 6 months.
Antioxidants + FSHDrug
Also called Antioxidants, follicle-stimulating hormone
Participants will receive the same antioxidant regimen plus FSH 150 IU administered subcutaneously three times weekly for 6 months.
Antioxidants AloneDrug
Participants will receive antioxidant therapy consisting of vitamin C 1000 mg/day, vitamin E 400 IU/day, L-carnitine, and zinc 25 mg/day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Antioxidants Alone | Active comparator | Participants will receive antioxidant therapy consisting of vitamin C 1000 mg/day, vitamin E 400 IU/day, L-carnitine, and zinc 25 mg/day for 6 months. Receives: Drug: Antioxidants + Clomiphene Citrate; Drug: Antioxidants + FSH |
| Antioxidants + Clomiphene Citrate | Experimental | Participants will receive the same antioxidant regimen plus clomiphene citrate 50 mg orally every other day for 6 months. Receives: Drug: Antioxidants + FSH; Drug: Antioxidants Alone |
| Antioxidants + FSH | Experimental | Participants will receive the same antioxidant regimen plus FSH 150 IU administered subcutaneously three times weekly for 6 months. Receives: Drug: Antioxidants + Clomiphene Citrate; Drug: Antioxidants Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sperm Concentration
Change in sperm concentration, measured in million sperm/mL, from baseline to 6 months after initiation of treatment.
Measured: Baseline and 6 months
Change in Sperm Motility
Change in sperm motility, measured as the percentage of motile sperm, from baseline to 6 months after initiation of treatment.
Measured: Baseline and 6 months
Change in Sperm Morphology
Change in normal sperm morphology from baseline to 6 months after initiation of treatment.
Measured: from baseline to 6 months
Secondary outcomes (8)
Change in oxidative stress / oxidation-reduction potential
Change in seminal oxidative stress measured by oxidation-reduction potential (ORP).
Measured: Baseline and 6 months
Change in sperm DNA fragmentation
Change in sperm DNA fragmentation, measured using the study's specified sperm function testing method.
Measured: Baseline and 6 months
Change in follicle-stimulating hormone
Change in serum FSH concentration from baseline to 6 months.
Measured: Baseline to 6 months
Change in Luteinizing Hormone
Change in serum luteinizing hormone (LH) concentration from baseline to 6 months.
Measured: From baseline to 6 months.
Change in Testosterone
Change in serum testosterone concentration from baseline to 6 months.
Measured: from baseline to 6 months
Change in Estradiol
Change in serum estradiol concentration from baseline to 6 months.
Measured: baseline to 6 months
Treatment Tolerability and Adverse Events
Assessment of treatment tolerability and occurrence of adverse events during the treatment period.
Measured: From treatment initiation through 6 months
Medication Adherence
Assessment of adherence to the assigned study treatment during the treatment period.
Measured: From treatment initiation through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligoasthenoteratozoospermiaStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Model description
- Three-arm, prospective, randomized, open-label, parallel-group controlled trial comparing antioxidant therapy alone with antioxidant therapy combined with clomiphene citrate or FSH
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862725
- Sponsor's protocol ID
- MRC-01-25-1509
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07862725
- Acronym / sponsor ID
- MRC-01-25-1509
- Conditions
- Oligoasthenoteratozoospermia, Male Infertility
- Keywords
- Idiopathic infertility, Oligoasthenoteratozoospermi, Selective estrogen receptor modulators, FSH, Antioxidants, Clomiphene citrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 7 Oct 2026 (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.
This prospective randomized controlled trial will compare three treatment approaches for men with idiopathic oligoasthenoteratozoospermia (OAT), a condition characterized by abnormalities in sperm count, movement, and shape without an identified cause. Participants will be randomly assigned in a 1:1:1 ratio to receive antioxidant therapy alone, antioxidant therapy plus clomiphene citrate, or antioxidant therapy plus follicle-stimulating hormone (FSH) for 6 months.
The study will evaluate whether adding clomiphene citrate or FSH to antioxidant therapy improves semen parameters compared with antioxidant therapy alone. The main outcomes will include changes in sperm concentration, motility, and morphology. The study will also assess sperm function, hormonal changes, treatment adherence, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm, prospective, randomized, open-label, parallel-group controlled trial comparing antioxidant therapy alone with antioxidant therapy combined with clomiphene citrate or FSH
| Arm | Type | Receives |
|---|---|---|
| Antioxidants Alone | Active comparator | Drug: Antioxidants + Clomiphene Citrate, Drug: Antioxidants + FSHParticipants will receive antioxidant therapy consisting of vitamin C 1000 mg/day, vitamin E 400 IU/day, L-carnitine, and zinc 25 mg/day for 6 months. |
| Antioxidants + Clomiphene Citrate | Experimental | Drug: Antioxidants + FSH, Drug: Antioxidants AloneParticipants will receive the same antioxidant regimen plus clomiphene citrate 50 mg orally every other day for 6 months. |
| Antioxidants + FSH | Experimental | Drug: Antioxidants + Clomiphene Citrate, Drug: Antioxidants AloneParticipants will receive the same antioxidant regimen plus FSH 150 IU administered subcutaneously three times weekly for 6 months. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male patients aged 21 to 50 years
- Diagnosed with idiopathic oligoasthenoteratozoospermia
- Sperm concentration ≥2 million/mL on at least one semen analysis
- FSH <8.0 IU/L
- Normal serum testosterone
Key exclusion criteria (15 listed)
- History of cryptorchidism.
- Previous orchidopexy.
- Previous testicular torsion.
- Previous testicular trauma.
- History of chemotherapy.
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 |
|---|---|---|
| Antioxidants + Clomiphene CitrateAlso: Clomiphene Citrate, AntioxidantsParticipants will receive the same antioxidant regimen as the active comparator arm plus clomiphene citrate 50 mg orally every other day for 6 months. | Drug | Antioxidants + FSH, Antioxidants Alone |
| Antioxidants + FSHAlso: Antioxidants, follicle-stimulating hormoneParticipants will receive the same antioxidant regimen plus FSH 150 IU administered subcutaneously three times weekly for 6 months. | Drug | Antioxidants + Clomiphene Citrate, Antioxidants Alone |
| Antioxidants AloneParticipants will receive antioxidant therapy consisting of vitamin C 1000 mg/day, vitamin E 400 IU/day, L-carnitine, and zinc 25 mg/day for 6 months | Drug | Antioxidants + Clomiphene Citrate, Antioxidants + FSH |
Primary outcome
Change in Sperm Concentration
Time frame: Baseline and 6 months
Change in sperm concentration, measured in million sperm/mL, from baseline to 6 months after initiation of treatment.
Change in Sperm Motility
Time frame: Baseline and 6 months
Change in sperm motility, measured as the percentage of motile sperm, from baseline to 6 months after initiation of treatment.
Change in Sperm Morphology
Time frame: from baseline to 6 months
Change in normal sperm morphology from baseline to 6 months after initiation of treatment.
8 secondary outcomes
Change in oxidative stress / oxidation-reduction potential
Time frame: Baseline and 6 months
Change in sperm DNA fragmentation
Time frame: Baseline and 6 months
Change in follicle-stimulating hormone
Time frame: Baseline to 6 months
Change in Luteinizing Hormone
Time frame: From baseline to 6 months.
Change in Testosterone
Time frame: from baseline to 6 months
Change in Estradiol
Time frame: baseline to 6 months
Treatment Tolerability and Adverse Events
Time frame: From treatment initiation through 6 months
Medication Adherence
Time frame: From treatment initiation through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Dr. Nadir Ibrahim Fadol contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antioxidants + Clomiphene Citrate, Antioxidants + FSH and Antioxidants Alone in people with Oligoasthenoteratozoospermia and Male Infertility, run by Hamad Medical Corporation at 1 site in Qatar.
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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 7 Oct 2026. 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 Qatar. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Haitham Tharwat El-Bardisi (66426664 ext. 00974, Helbardisi@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sperm Concentration (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. 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 7 Oct 2026.