Role of Nutritional Support in Idiopathic Male Infertility

Sponsor

NATURAmedicatrix Sàrl (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03588949

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male	Dietary Supplement: Dietary Supplement with L-carnitine (FertilHom) Dietary Supplement: Control Dietary Supplement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

Role of Nutritional Support in Idiopathic Male Infertility: a Randomized Dietary Study

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Dietary Supplement Dietary Supplement with L-carnitine (FertilHom)	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
Placebo Comparator: Control Dietary Supplement Dietary Supplement with 50% RDA of beta-carotene	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

Arm

Intervention/Treatment

Experimental: Active Dietary Supplement

Dietary Supplement with L-carnitine (FertilHom)

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

Placebo Comparator: Control Dietary Supplement

Dietary Supplement with 50% RDA of beta-carotene

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

Outcome Measures

Primary Outcome Measures

Rate of normalization of spermogram [4 months]
None deviation found in spermogram

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedianaStatistics	Lviv		Ukraine	79012

Sponsors and Collaborators

NATURAmedicatrix Sàrl

Investigators

Study Director: Marco Pietteur, NATURAmedicatrix Sarl

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NATURAmedicatrix Sàrl

ClinicalTrials.gov Identifier:

NCT03588949

Other Study ID Numbers:

NATURAmedicatrix-FE-0001-M

First Posted:

Jul 17, 2018

Last Update Posted:

Feb 26, 2020

Last Verified:

Aug 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Male

Study Results

No Results Posted as of Feb 26, 2020