Infertility, MaleNCT03588949
Role of Nutritional Support in Idiopathic Male Infertility
A study testing Dietary Supplement with L-carnitine (FertilHom) in people with Infertility, Male, run by NATURAmedicatrix Sàrl at 1 site in Ukraine.
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… Read more about this study
- Who is it for?
- Ages 21 to 50 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Dietary Supplement with L-carnitine (FertilHom)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Oct 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
MedianaStatistics
Lviv, 79012
Sergiy V Gerasymov, MD,PhD
About this study
Official title: Role of Nutritional Support in Idiopathic Male Infertility: a Randomized Dietary Study
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
- Being tested
- Dietary Supplement with L-carnitine (FertilHom), Control Dietary Supplement
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement with L-carnitine (FertilHom)Dietary supplement
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 SupplementDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Active Dietary Supplement | Experimental | Dietary Supplement with L-carnitine (FertilHom) Receives: Dietary Supplement: Dietary Supplement with L-carnitine (FertilHom) |
| Control Dietary Supplement | Placebo comparator | Dietary Supplement with 50% RDA of beta-carotene Receives: Dietary Supplement: Control Dietary Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of normalization of spermogram
None deviation found in spermogram
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Oct 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NATURAmedicatrix Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco Pietteur, Study director, NATURAmedicatrix Sarl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588949
- Sponsor's protocol ID
- NATURAmedicatrix-FE-0001-M
- Status last verified
- Aug 2019
- First submitted
- 26 Jun 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nutritional Support in Idiopathic Male Infertility: a Randomized Dietary Study
- ClinicalTrials.gov ID
- NCT03588949
- Acronym / sponsor ID
- NATURAmedicatrix-FE-0001-M
- Conditions
- Infertility, Male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NATURAmedicatrix SàrlIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Dietary Supplement | Experimental | Dietary Supplement: Dietary Supplement with L-carnitine (FertilHom)Dietary Supplement with L-carnitine (FertilHom) |
| Control Dietary Supplement | Placebo comparator | Dietary Supplement: Control Dietary SupplementDietary Supplement with 50% RDA of beta-carotene |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active Dietary Supplement |
| Control Dietary Supplement1 stick of the TDSwill 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 |
Primary outcome
Rate of normalization of spermogram
Time frame: 4 months
None deviation found in spermogram
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
Related trials for Infertility, Male
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Pietteur study director
NATURAmedicatrix Sarl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement with L-carnitine (FertilHom) in people with Infertility, Male, run by NATURAmedicatrix Sàrl at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergiy V Gerasymov, MD,PhD (+380679375951, mediana.statistics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of normalization of spermogram (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.