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The Effect of a Multimodal Lifestyle Program on Male Fertility

Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761250
Enrollment
26
Registered
2021-02-18
Start date
2021-02-15
Completion date
2022-09-12
Last updated
2022-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male

Keywords

Male infertility, Semen quality, Lifestyle intervention

Brief 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

Interventions

DIETARY_SUPPLEMENTLifestyle

Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation

Sponsors

Peter Humaidan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Men of couples who are about to start 2nd or 3rd fertility treatment * \> 18 years old * Sperm concentration between 2-40 mill./ml

Exclusion criteria

* Use of testicular sperm

Design outcomes

Primary

MeasureTime frameDescription
Increase in the total amount of motil sperm in male patients undergoing fertility treatment90 daysChange in classical sperm parameters

Secondary

MeasureTime frameDescription
Change in DNA fragmentation index (DFI)90 daysDFI is measured by Comet Assay
Changes in parameters for metabolic syndrome90 daysWeight in kilograms
Change in plasma lipids90 daysPlasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026