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Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial

ConditionsOligoasthenoteratozoospermiaMale Infertility
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age21-50
SponsorHamad Medical Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of cryptorchidism.

Previous orchidopexy.

Previous testicular torsion.

Previous testicular trauma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antioxidants + Clomiphene Citrate

    Drug

    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 + FSH

    Drug

    Participants will receive the same antioxidant regimen plus FSH 150 IU administered subcutaneously three times weekly for 6 months.

  • Antioxidants Alone

    Drug

    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

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: Antioxidants AloneActive comparator 2 interventions
Group B: Antioxidants + Clomiphene CitrateExperimental treatment 2 interventions
Group C: Antioxidants + FSHExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Sperm Concentration

Change in sperm concentration, measured in million sperm/mL, from baseline to 6 months after initiation of treatment.

Time frame
Baseline and 6 months
2

Change in Sperm Motility

Change in sperm motility, measured as the percentage of motile sperm, from baseline to 6 months after initiation of treatment.

Time frame
Baseline and 6 months
3

Change in Sperm Morphology

Change in normal sperm morphology from baseline to 6 months after initiation of treatment.

Time frame
from baseline to 6 months

Secondary outcomes

1

Change in oxidative stress / oxidation-reduction potential

Change in seminal oxidative stress measured by oxidation-reduction potential (ORP).

Time frame
Baseline and 6 months
2

Change in sperm DNA fragmentation

Change in sperm DNA fragmentation, measured using the study's specified sperm function testing method.

Time frame
Baseline and 6 months
3

Change in follicle-stimulating hormone

Change in serum FSH concentration from baseline to 6 months.

Time frame
Baseline to 6 months
4

Change in Luteinizing Hormone

Change in serum luteinizing hormone (LH) concentration from baseline to 6 months.

Time frame
From baseline to 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamad Medical Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: