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
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.
- 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