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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03588949
Other study ID # NATURAmedicatrix-FE-0001-M
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date April 30, 2020

Study information

Verified date August 2019
Source NATURAmedicatrix Sàrl
Contact Sergiy V Gerasymov, MD,PhD
Phone +380679375951
Email mediana.statistics@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender Male
Age group 21 Years to 50 Years
Eligibility Inclusion Criteria:

1. Informed consent form signed;

2. Age: 21-50;

3. Idiopathic male infertility;

4. Idiopathic oligo- and/or astheno- and/or teratozoospermia;

5. Stated availability throughout the study period and a mobile phone

Exclusion Criteria:

1. Allergy to any component of the dietary supplement;

2. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility;

3. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility;

4. Inflammatory bowel disease;

5. Known moderate to severe disease of any systems;

6. Known or suspected sexually transmitted diseases;

7. Alcohol or drug addiction of any couple counterpart as suspected by investigator;

8. Difficulty to comprehend study requirements as judged by investigator;

9. Use of any investigational product within the previous 3 months before entering the study;

10. Use of any drugs that stimulate or suppress spermatogenesis within previous 3 months

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Ukraine MedianaStatistics Lviv

Sponsors (1)

Lead Sponsor Collaborator
NATURAmedicatrix Sàrl

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of normalization of spermogram None deviation found in spermogram 4 months
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