Myo-inositolPhase 3MYO-VARNCT07915388
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
A Phase 3 study testing Experimental Arm Intervention: Myo-inositol and Conventional Antioxidants in people with Myo-inositol and Post Varicocelectomy, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Myo-inositol, Post Varicocelectomy, Infertile Men
- What is being tested?
- Experimental Arm Intervention: Myo-inositol and Conventional Antioxidants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Oct 2026to 1 Jul 2027
- Phase
- Phase 3
- 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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Myo-inositol, Post Varicocelectomy, Infertile Men, Varicocele
- Being tested
- Experimental Arm Intervention: Myo-inositol, Conventional Antioxidants, Group C (Control)
- Keywords
- Male Infertility, Myo-inositol, Varicocele, Antioxidants, Varicocelectomy
- Medical subject headings
- Varicocele, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Arm Intervention: Myo-inositolDrug
Microscopic subinguinal varicocelectomy followed by oral myo-inositol 2 g tablets twice daily for 3 to 6 months post-surgery.
Conventional AntioxidantsDrug
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.
Group C (Control)Other
Microscopic subinguinal varicocelectomy alone with no adjuvant medical therapy post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Myo-inositol | Experimental | Surgical Intervention: Microscopic subinguinal varicocelectomy. Drug/Supplement: Oral Myo-inositol 2g tablets, twice daily for 3 to 6 months post-surgery. Receives: Drug: Experimental Arm Intervention: Myo-inositol |
| Group B: Conventional Antioxidants | Active comparator | 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. Receives: Drug: Conventional Antioxidants |
| Group C: Varicocelectomy Alone | Placebo comparator | Microscopic subinguinal varicocelectomy alone with no adjuvant medical therapy post-surgery. Receives: Other: Group C (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
semen analysis sperm concentration
Assessment of improvement in semen analysis parameters sperm concentration
Measured: 3 and 6 months post-intervention.
semen analysis sperm motility
Assessment of improvement in semen analysis parameters sperm motility
Measured: 3 and 6 months post-intervention.
semen analysis sperm morphology
Assessment of improvement in semen analysis parameters: sperm morphology
Measured: 3 and 6 months post-intervention.
Secondary outcomes (2)
Spontaneous pregnancy rate (incidence of pregnancy)
Spontaneous pregnancy rate (incidence of pregnancy)
Measured: within 1 year postoperative
Incidence and profile of medical treatment side effects.
Incidence and profile of medical treatment side effects.
Measured: within 3 to 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start26 Oct 2026 (estimated)
- Primary completion29 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myo-inositolStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, open-label, 3-arm parallel-group interventional trial involving 150 adult male patients with Grade II-III clinical varicocele undergoing microscopic subinguinal varicocelectomy. Eligible participants are randomized in a 1:1:1 ratio using a computer-generated random sequence (via randomizer.org) with allocation concealed in opaque sealed envelopes. All participants receive standard microscopic subinguinal varicocelectomy. Post-operatively, patients are allocated to one of three parallel arms for a 3- to 6-month treatment duration: Group A (Myo-inositol Arm): Surgical varicocelectomy followed by oral Myo-inositol (2 g twice daily). Group B (Active Comparator Arm): Surgical varicocelectomy followed by oral conventional antioxidants (500 mg o once daily, 1000 mg of L-carnitine twice daily, and 10 mg of twice daily). Group C (Control Arm): Surgical varicocelectomy alone without post-operative medical therapy. Outcomes, including seminal fl
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Dogha, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915388
- Sponsor's protocol ID
- R-872
- Acronym
- MYO-VAR
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Myo-inositol Add on Post Varicocelectomy Versus Add on Conventional Antioxidants or Varicocelectomy Alone in Infertile Patients
- ClinicalTrials.gov ID
- NCT07915388
- Acronym / sponsor ID
- MYO-VAR / R-872
- Conditions
- Myo-inositol, Post Varicocelectomy, Infertile Men, Varicocele
- Keywords
- Male Infertility, Myo-inositol, Varicocele, Antioxidants, Varicocelectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Nov 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective, randomized, open-label, 3-arm parallel-group interventional trial involving 150 adult male patients with Grade II-III clinical varicocele undergoing microscopic subinguinal varicocelectomy. Eligible participants are randomized in a 1:1:1 ratio using a computer-generated random sequence (via randomizer.org) with allocation concealed in opaque sealed envelopes. All participants receive standard microscopic subinguinal varicocelectomy. Post-operatively, patients are allocated to one of three parallel arms for a 3- to 6-month treatment duration: Group A (Myo-inositol Arm): Surgical varicocelectomy followed by oral Myo-inositol (2 g twice daily). Group B (Active Comparator Arm): Surgical varicocelectomy followed by oral conventional antioxidants (500 mg o once daily, 1000 mg of L-carnitine twice daily, and 10 mg of twice daily). Group C (Control Arm): Surgical varicocelectomy alone without post-operative medical therapy. Outcomes, including seminal fl
| Arm | Type | Receives |
|---|---|---|
| Group A: Myo-inositol | Experimental | Drug: Experimental Arm Intervention: Myo-inositolSurgical Intervention: Microscopic subinguinal varicocelectomy. Drug/Supplement: Oral Myo-inositol 2g tablets, twice daily for 3 to 6 months post-surgery. |
| Group B: Conventional Antioxidants | Active comparator | Drug: Conventional AntioxidantsSurgical 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. |
| Group C: Varicocelectomy Alone | Placebo comparator | Other: Group C (Control)Microscopic subinguinal varicocelectomy alone with no adjuvant medical therapy post-surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Experimental Arm Intervention: Myo-inositolMicroscopic subinguinal varicocelectomy followed by oral myo-inositol 2 g tablets twice daily for 3 to 6 months post-surgery. | Drug | Group A: Myo-inositol |
| Conventional AntioxidantsMicroscopic 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. | Drug | Group B: Conventional Antioxidants |
| Group C (Control)Microscopic subinguinal varicocelectomy alone with no adjuvant medical therapy post-surgery. | Other | Group C: Varicocelectomy Alone |
Primary outcome
semen analysis sperm concentration
Time frame: 3 and 6 months post-intervention.
Assessment of improvement in semen analysis parameters sperm concentration
semen analysis sperm motility
Time frame: 3 and 6 months post-intervention.
Assessment of improvement in semen analysis parameters sperm motility
semen analysis sperm morphology
Time frame: 3 and 6 months post-intervention.
Assessment of improvement in semen analysis parameters: sperm morphology
2 secondary outcomes
Spontaneous pregnancy rate (incidence of pregnancy)
Time frame: within 1 year postoperative
Incidence and profile of medical treatment side effects.
Time frame: within 3 to 6 months postoperative
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 4 Nov 2026.
- Individual participant dataSharing planned: 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.
Related trials for Myo-inositol
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Recruiting
Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
PCOS (Polycystic Ovary Syndrome), Insulin Resistance
Active, not recruiting
Myo-Inositol and Folic Acid for Improving Inflammation in Polycystic Ovary Syndrome
Inflammation Biomarkers, Poly Cystic Ovary Syndrome
Recruiting
Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
Thyroid Nodule
Recruiting
The Impact of Myo-Inositol on Glycemic Control and Oxidative Stress in Gestational Diabetes Mellitus
Gestational Diabetes Mellitus (GDM)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental Arm Intervention: Myo-inositol and Conventional Antioxidants in people with Myo-inositol and Post Varicocelectomy, run by Fayoum University Hospital at 1 site in Egypt.
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 5 inclusion and 7 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 4 Nov 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 Egypt. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mohamed Dogha, MD (01010044612 ext. 00201010044612, mma16@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
semen analysis sperm concentration (time frame: 3 and 6 months post-intervention.). 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 4 Nov 2026.