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DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health (ReproDNA)

Primary Purpose

Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Life style
Sponsored by
Regionshospitalet Viborg, Skive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring male infertility, DNA fragmentation Index, DFI, life style intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • DNA fragmentation index above 15 %

Exclusion Criteria:

  • TESA/PESA

Sites / Locations

  • Fertility Clinic Skive, Skive Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Change in DNA fragmentation index (DFI)
DFI is measured by SCSA

Secondary Outcome Measures

Change in classical sperm parameters
Sperm count
Change in classical sperm parameters
Sperm motility (movement)
Change in classical sperm parameters
Sperm morphology (structure)
Change in classical sperm parameters
Sperm concentration in mio sperm pr. milliliter
Changes in parameters for metabolic syndrome
Weight in kilograms
Changes in parameters for metabolic syndrome
Blood pressure in millimeters of mercury
Changes in parameters for metabolic syndrome
Hemoglobin A1c in mmol/L
Changes in parameters for metabolic syndrome
Body mass index in kg/m^2
Change in plasma lipids
Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Change in serum D-vitamin levels
25-hydroxy vitamin D (D3+D2) measured as nmol/l
Number of participants achieving live birth
Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.
Number of participants with clinical pregnancy
Measurement of heart beat by ultrasound scan
Number of participants with biochemical pregnancy
Increase in serum hCG levels
Cumulative live birth rate
Live births originating from one controlled stimulation.

Full Information

First Posted
November 8, 2019
Last Updated
April 26, 2023
Sponsor
Regionshospitalet Viborg, Skive
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1. Study Identification

Unique Protocol Identification Number
NCT04183374
Brief Title
DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health
Acronym
ReproDNA
Official Title
DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionshospitalet Viborg, Skive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A lifestyle intervention study in infertile males of couples seeking fertility treatment with a DNA fragmentation index (DFI) above 15 percentage. A reduction in DNA fragmentation index of 10 percentage points is expected after 3-4 months of intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
male infertility, DNA fragmentation Index, DFI, life style intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
Intervention Type
Other
Intervention Name(s)
Life style
Intervention Description
Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
Primary Outcome Measure Information:
Title
Change in DNA fragmentation index (DFI)
Description
DFI is measured by SCSA
Time Frame
3-4 months after inclusion
Secondary Outcome Measure Information:
Title
Change in classical sperm parameters
Description
Sperm count
Time Frame
3-4 months after inclusion
Title
Change in classical sperm parameters
Description
Sperm motility (movement)
Time Frame
3-4 months after inclusion
Title
Change in classical sperm parameters
Description
Sperm morphology (structure)
Time Frame
3-4 months after inclusion
Title
Change in classical sperm parameters
Description
Sperm concentration in mio sperm pr. milliliter
Time Frame
3-4 months after inclusion
Title
Changes in parameters for metabolic syndrome
Description
Weight in kilograms
Time Frame
3-4 months after inclusion
Title
Changes in parameters for metabolic syndrome
Description
Blood pressure in millimeters of mercury
Time Frame
3-4 months after inclusion
Title
Changes in parameters for metabolic syndrome
Description
Hemoglobin A1c in mmol/L
Time Frame
3-4 months after inclusion
Title
Changes in parameters for metabolic syndrome
Description
Body mass index in kg/m^2
Time Frame
3-4 months after inclusion
Title
Change in plasma lipids
Description
Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides
Time Frame
3-4 months after inclusion
Title
Change in serum D-vitamin levels
Description
25-hydroxy vitamin D (D3+D2) measured as nmol/l
Time Frame
3-4 months after inclusion
Title
Number of participants achieving live birth
Description
Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.
Time Frame
Week 30-42 of pregnancy
Title
Number of participants with clinical pregnancy
Description
Measurement of heart beat by ultrasound scan
Time Frame
Week 7-8 of pregnancy
Title
Number of participants with biochemical pregnancy
Description
Increase in serum hCG levels
Time Frame
Day 14-17 of pregnancy
Title
Cumulative live birth rate
Description
Live births originating from one controlled stimulation.
Time Frame
9-24 months after inclusion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DNA fragmentation index above 15 % Exclusion Criteria: TESA/PESA
Facility Information:
Facility Name
Fertility Clinic Skive, Skive Regional Hospital
City
Skive
ZIP/Postal Code
7800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Humaidan, DMSc
Phone
+4578445760
Email
fertilitetsklinikken@midt.rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health

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