Role of Nutritional Support in Idiopathic Male Infertility
1 other identifier
interventional
100
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFebruary 26, 2020
August 1, 2019
1.6 years
June 26, 2018
February 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of normalization of spermogram
None deviation found in spermogram
4 months
Study Arms (2)
Active Dietary Supplement
EXPERIMENTALDietary Supplement with L-carnitine (FertilHom)
Control Dietary Supplement
PLACEBO COMPARATORDietary Supplement with 50% RDA of beta-carotene
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Informed consent form signed;
- Age: 21-50;
- Idiopathic male infertility;
- Idiopathic oligo- and/or astheno- and/or teratozoospermia;
- Stated availability throughout the study period and a mobile phone
You may not qualify if:
- Allergy to any component of the dietary supplement;
- Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility;
- Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility;
- Inflammatory bowel disease;
- Known moderate to severe disease of any systems;
- Known or suspected sexually transmitted diseases;
- Alcohol or drug addiction of any couple counterpart as suspected by investigator;
- Difficulty to comprehend study requirements as judged by investigator;
- Use of any investigational product within the previous 3 months before entering the study;
- Use of any drugs that stimulate or suppress spermatogenesis within previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MedianaStatistics
Lviv, 79012, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marco Pietteur
NATURAmedicatrix Sarl
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 17, 2018
Study Start
October 1, 2018
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
February 26, 2020
Record last verified: 2019-08