A Phase 3 interventional study of Experimental Arm Intervention: Myo-inositol and Conventional Antioxidants in Myo-inositol, Post Varicocelectomy and Infertile Men, sponsored by Fayoum University Hospital. Not yet recruiting at 1 site in Egypt. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Fayoum University Hospital · Phase 3, Interventional, and Treatment
The purpose of this open-label, 3-arm randomized controlled trial is to compare the clinical efficacy and safety of adding oral myo-inositol versus conventional oral antioxidants (vitamin C, L-carnitine, and zinc) versus surgery alone following microscopic subinguinal varicocelectomy in infertile adult males with clinical varicocele.
Varicocele is present in approximately 40% of infertile males. While microscopic varicocelectomy remains the gold-standard surgical correction, post-operative oxidative stress and impaired spermatogenesis frequently require adjunctive metabolic or antioxidant support. Myo-inositol plays a critical role in Sertoli cell function, sperm maturation, mitochondrial energy production, and intracellular calcium mobilization essential for sperm hyperactivation. In this prospective study, 150 male patients with clinical Grade II-III varicocele undergoing microscopic subinguinal varicocelectomy at Fayoum University Hospitals will be randomly assigned (1:1:1) into three parallel groups: Group A: Receives oral myo-inositol supplementation for 3-6 months postoperatively. Group B: Receives conventional oral antioxidant combination therapy for 3-6 months post-operatively. Group C: Receives no adjuvant medical treatment post-operatively. All subjects undergo standardized preoperative evaluation (hormone profile, seminal fluid analysis, scrotal duplex) and postoperative follow-up to assess semen parameter improvement, clinical pregnancy rates, and treatment side effects.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's planned enrollment of 150 is above the median of 72 across 36 interventional studies indexed under Varicocele.
Browse Varicocele studies →Fayoum University Hospital is the lead sponsor of 77 studies on the registry; 14 are open to participants now.
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Clinically palpable Grade II or Grade III varicocele undergoing varicocelectomy.
Presence of primary or secondary infertility.
Impaired semen analysis parameters.
Reduced testicular volume.
Exclusion Criteria:
Pediatric (infants) or elderly populations.
Sub-clinical varicocele.
History of previous varicocelectomy operations.
Systemic vascular or medical diseases affecting arterial flow (e.g., diabetes mellitus, hypertension, liver disease, hypercholesterolemia).
Active genital tract infections.
Hormonal abnormalities or autism.
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Surgical Intervention: Microscopic subinguinal varicocelectomy. Drug/Supplement: Oral Myo-inositol 2g tablets, twice daily for 3 to 6 months post-surgery.
Drug: Experimental Arm Intervention: Myo-inositol
Surgical Intervention: Microscopic subinguinal varicocelectomy. Drug/Supplement: Oral Vitamin C (500mg daily) + L-Carnitine (1000mg twice daily) + Zinc (10mg twice daily) for 3 to 6 months post-surgery.
Drug: Conventional Antioxidants
Microscopic subinguinal varicocelectomy alone with no adjuvant medical therapy post-surgery.
Other: Group C (Control)
Microscopic subinguinal varicocelectomy followed by oral myo-inositol 2 g tablets twice daily for 3 to 6 months post-surgery.
Microscopic subinguinal varicocelectomy followed by oral vitamin C (500 mg daily) + L-carnitine (1000 mg twice daily) + zinc (10 mg twice daily) for 3 to 6 months post-surgery.
Microscopic subinguinal varicocelectomy alone with no adjuvant medical therapy post-surgery.
semen analysis sperm concentration
Assessment of improvement in semen analysis parameters sperm concentration
Time frame: 3 and 6 months post-intervention.
semen analysis sperm motility
Assessment of improvement in semen analysis parameters sperm motility
Time frame: 3 and 6 months post-intervention.
semen analysis sperm morphology
Assessment of improvement in semen analysis parameters: sperm morphology
Time frame: 3 and 6 months post-intervention.
Spontaneous pregnancy rate (incidence of pregnancy)
Spontaneous pregnancy rate (incidence of pregnancy)
Time frame: within 1 year postoperative
Incidence and profile of medical treatment side effects.
Incidence and profile of medical treatment side effects.
Time frame: within 3 to 6 months postoperative
Plan to share: No — Individual participant data (IPD) will not be made publicly available in open repositories to protect patient privacy and confidentiality, in accordance with the ethical protocol approved by the Institutional Ethical Committee of Fayoum University. Participants provided written informed consent for the publication of aggregated statistical results only, and consent was not obtained for public sharing of individual-level clinical data.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Fayoum University Hospital