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Role of Nutritional Support in Idiopathic Male Infertility

NCT03588949 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-02-26

No results posted yet for this study

Summary

Approximately 100 males with idiopathic infertility and oligo- and/or astheno- and/or and/or teratozoospermia and fertile woman will take a Test dietary supplement (TDS), containing carnitine, vitamins and trace elements (active group) or carotene (control group) for 6 months (50 subjects in active and control groups). Before intake, and 2 and 4 months after the commencement of TDS, all males will have spermogram. After 6-month use of the TDS and during the 12th month of the study, couples will be screened for conception, pregnancy, and a newborn

Conditions

  • Infertility, Male

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement with L-carnitine (FertilHom)

1 stick of the TDS (vitamins, trace elements with carnitine) will be given 1 time daily in the evening before meals for 6 months or until pregnancy, depending whatever comes first

DIETARY_SUPPLEMENT

Control Dietary Supplement

1 stick of the TDSwill be given 1 time daily in the evening before meals for 6 months or until pregnancy, depending whatever comes first

Sponsors & Collaborators

  • NATURAmedicatrix Sàrl

    lead INDUSTRY

Principal Investigators

  • Marco Pietteur · NATURAmedicatrix Sarl

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03588949 on ClinicalTrials.gov