NCT04761250

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

February 12, 2021

Last Update Submit

September 26, 2022

Conditions

Infertility, Male

Keywords

Male infertilitySemen qualityLifestyle intervention

Outcome Measures

Primary Outcomes (1)

  • Increase in the total amount of motil sperm in male patients undergoing fertility treatment

    Change in classical sperm parameters

    90 days

Secondary Outcomes (5)

  • Change in DNA fragmentation index (DFI)

    90 days

  • Changes in parameters for metabolic syndrome

    90 days

  • Changes in parameters for metabolic syndrome

    90 days

  • Changes in parameters for metabolic syndrome

    90 days

  • Change in plasma lipids

    90 days

Study Arms (1)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Lifestyle

Interventions

LifestyleDIETARY_SUPPLEMENT

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

Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Use of testicular sperm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic Skive, Skive Regional Hospital

Skive, 7800, Denmark

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Consultant

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 18, 2021

Study Start

February 15, 2021

Primary Completion

June 1, 2022

Study Completion

September 12, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)