Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men (MYO-VAR)
Comparative Study Between Myo-inositol Add on Post Varicocelectomy Versus Add on Conventional Antioxidants or Varicocelectomy Alone in Infertile Patients
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Mohamed Dogha, MD
- Telefonnummer: 00201010044612 01010044612
- E-mail: mma16@fayoum.edu.eg
Studiesteder
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Al Fayyum, Egypten, 63514
- Mohamed Mahmoud Dogha
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult male patients.
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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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group A: Myo-inositol
Surgical Intervention: Microscopic subinguinal varicocelectomy. Drug/Supplement: Oral Myo-inositol 2g tablets, twice daily for 3 to 6 months post-surgery. |
Microscopic subinguinal varicocelectomy followed by oral myo-inositol 2 g tablets twice daily for 3 to 6 months post-surgery. |
|
Aktiv komparator: Group B: Conventional Antioxidants
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. |
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. |
|
Placebo komparator: Group C: Varicocelectomy Alone
Microscopic subinguinal varicocelectomy alone with no adjuvant medical therapy post-surgery. |
Microscopic subinguinal varicocelectomy alone with no adjuvant medical therapy post-surgery. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
semen analysis sperm concentration
Tidsramme: 3 and 6 months post-intervention.
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Assessment of improvement in semen analysis parameters sperm concentration |
3 and 6 months post-intervention.
|
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semen analysis sperm motility
Tidsramme: 3 and 6 months post-intervention.
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Assessment of improvement in semen analysis parameters sperm motility |
3 and 6 months post-intervention.
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semen analysis sperm morphology
Tidsramme: 3 and 6 months post-intervention.
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Assessment of improvement in semen analysis parameters: sperm morphology |
3 and 6 months post-intervention.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Spontaneous pregnancy rate (incidence of pregnancy)
Tidsramme: within 1 year postoperative
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Spontaneous pregnancy rate (incidence of pregnancy) |
within 1 year postoperative
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Incidence and profile of medical treatment side effects.
Tidsramme: within 3 to 6 months postoperative
|
Incidence and profile of medical treatment side effects. |
within 3 to 6 months postoperative
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R-872
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
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