MedPath

utritional supplements in Sub-fertile Males

Phase 4
Completed
Conditions
Health Condition 1: null- Sub-fertility
Registration Number
CTRI/2011/06/001816
Lead Sponsor
Meyer Organics Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
104
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Increase in Sperm ConcentrationTimepoint: Baseline (Pretreatment)and day 30, 60, 90, 120, 150 and 180
Secondary Outcome Measures
NameTimeMethod
Change in Semen volume,Total sperm count,Motility of sperms <br/ ><br>Morphology of sperm,Semen liquefaction time,Semenâ??s relative viscosity to water <br/ ><br>ï?§Incidence of pregnancy (Pregnancy will be diagnosed by urine pregnancy test) <br/ ><br>Subjective safety and tolerabilityTimepoint: Baseline (Pretreatment)and day 30, 60, 90, 120, 150 and 180
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