Infertility, MaleNCT04761250
The Effect of a Multimodal Lifestyle Program on Male Fertility
A study testing Lifestyle in people with Infertility, Male, run by Peter Humaidan at 1 site in Denmark.
Trial summary
A non-pharmacological study, which examines the effect of lifestyle intervention on sperm quality among men in fertility treatment. The primary endpoint is to increase the total amount of motile sperm in male patients undergoing fertility treatment Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Lifestyle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2021to 12 Sep 2022
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men of couples who are about to start 2nd or 3rd fertility treatment
- > 18 years old
- Sperm concentration between 2-40 mill./ml
Who cannot join
- Use of testicular sperm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment
A non-pharmacological study, which examines the effect of lifestyle intervention on sperm quality among men in fertility treatment.
The primary endpoint is to increase the total amount of motile sperm in male patients undergoing fertility treatment
- Conditions
- Infertility, Male
- Being tested
- Lifestyle
- Keywords
- Male infertility, Semen quality, Lifestyle intervention
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleDietary supplement
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation Receives: Dietary Supplement: Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in the total amount of motil sperm in male patients undergoing fertility treatment
Change in classical sperm parameters
Measured: 90 days
Secondary outcomes (5)
Change in DNA fragmentation index (DFI)
DFI is measured by Comet Assay
Measured: 90 days
Changes in parameters for metabolic syndrome
Weight in kilograms
Measured: 90 days
Changes in parameters for metabolic syndrome
BMI (Body Mass Index). Weight and height will be combined to report BMI in kg/m^2
Measured: 90 days
Changes in parameters for metabolic syndrome
Blood pressure in millimeters of mercury
Measured: 90 days
Change in plasma lipids
Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 Feb 2021
- Primary completion1 Jun 2022
- Study completion12 Sep 2022
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761250
- Sponsor's protocol ID
- 1-10-72-109-20
- Status last verified
- Sep 2022
- First submitted
- 12 Feb 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment
- ClinicalTrials.gov ID
- NCT04761250
- Acronym / sponsor ID
- 1-10-72-109-20
- Conditions
- Infertility, Male
- Keywords
- Male infertility, Semen quality, Lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 18 Feb 2021 (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.
A non-pharmacological study, which examines the effect of lifestyle intervention on sperm quality among men in fertility treatment.
The primary endpoint is to increase the total amount of motile sperm in male patients undergoing fertility treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: LifestyleLifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men of couples who are about to start 2nd or 3rd fertility treatment
- > 18 years old
- Sperm concentration between 2-40 mill./ml
Key exclusion criteria (1 listed)
- Use of testicular sperm
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 |
|---|---|---|
| LifestyleLifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation | Dietary supplement | Intervention |
Primary outcome
Increase in the total amount of motil sperm in male patients undergoing fertility treatment
Time frame: 90 days
Change in classical sperm parameters
5 secondary outcomes
Change in DNA fragmentation index (DFI)
Time frame: 90 days
Changes in parameters for metabolic syndrome
Time frame: 90 days
Changes in parameters for metabolic syndrome
Time frame: 90 days
Changes in parameters for metabolic syndrome
Time frame: 90 days
Change in plasma lipids
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle in people with Infertility, Male, run by Peter Humaidan at 1 site in Denmark.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 27 Sep 2022. 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 Denmark. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in the total amount of motil sperm in male patients undergoing fertility treatment (time frame: 90 days). 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 27 Sep 2022.