Back to resultsRole of Nutritional Support in Idiopathic Male Infertility
Primary Purpose
Infertility, Male
Status
Unknown status
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Dietary Supplement with L-carnitine (FertilHom)
Control Dietary Supplement
Sponsored by
About this trial
This is an interventional other trial for Infertility, Male
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- MedianaStatisticsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Dietary Supplement
Control Dietary Supplement
Arm Description
Dietary Supplement with L-carnitine (FertilHom)
Dietary Supplement with 50% RDA of beta-carotene
Outcomes
Primary Outcome Measures
Rate of normalization of spermogram
None deviation found in spermogram
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03588949
Brief Title
Role of Nutritional Support in Idiopathic Male Infertility
Official Title
Role of Nutritional Support in Idiopathic Male Infertility: a Randomized Dietary Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NATURAmedicatrix Sàrl
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Dietary Supplement
Arm Type
Experimental
Arm Description
Dietary Supplement with L-carnitine (FertilHom)
Arm Title
Control Dietary Supplement
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement with 50% RDA of beta-carotene
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement with L-carnitine (FertilHom)
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Dietary Supplement
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of normalization of spermogram
Description
None deviation found in spermogram
Time Frame
4 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergiy V Gerasymov, MD,PhD
Phone
+380679375951
Email
mediana.statistics@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Pietteur
Organizational Affiliation
NATURAmedicatrix Sarl
Official's Role
Study Director
Facility Information:
Facility Name
MedianaStatistics
City
Lviv
ZIP/Postal Code
79012
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergiy V Gerasymov, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
Role of Nutritional Support in Idiopathic Male Infertility
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