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Nutritional supplements in Sub-fertile Males

To Evaluate Efficacy & Safety of Multiple Micronutrient Supplement Preparation versus Placebo in Sub-fertile Males

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/06/001816
Enrollment
104
Registered
2011-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Sub-fertility

Interventions

Intervention1: Multiple Micronutrient Supplement plus Co-Q 10 enzyme: Tablet of MMS and Capsule of Co-Q 10 Twice daily together for 6 months Efficacy and Safety Assessment: Baseline and every month ti

Sponsors

Meyer Organics Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subject Inclusion Criteria -Willingness to provide written informed consent to participate in the study and willing to follow up -Age: Between 25 ?45 years Subfertile male who were not using any contraception for at least last one year -The female partner was defined as being fertile - -Presence of oligospermia, asthenospermia, teratospermia -Semen volume 1.5 ml -Sperm concentration 5 x106/ml and ≤ 15 x 106/ml -Motile count 40 % -Abnormal morphology of sperm characterized by 30% normal form

Exclusion criteria

Exclusion criteria: Patients already taking multivitamin supplementation -Presence of general and endocrinological disease -Patient with previous or present cryptorchidism, or genital obstruction -History of vasectomy, undescended testis prostate cancer, varicocele, hydrocoele -Patient requiring anti-infective agents -History of chemotherapy or radiation -History /presence of azoospermia

Design outcomes

Primary

MeasureTime frame
Increase in Sperm ConcentrationTimepoint: Baseline (Pretreatment)and day 30, 60, 90, 120, 150 and 180

Secondary

MeasureTime frame
Change in Semen volume,Total sperm count,Motility of sperms Morphology of sperm,Semen liquefaction time,Semenâ??s relative viscosity to water ï?§ Incidence of pregnancy (Pregnancy will be diagnosed by urine pregnancy test) Subjective safety and tolerabilityTimepoint: Baseline (Pretreatment)and day 30, 60, 90, 120, 150 and 180

Countries

India

Contacts

Public ContactOnkar Rathod

Ganorkar Hospital, Nashik

ranjit@ourangels.com02532583496

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026