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

• Sponsor: Regionshospitalet Viborg, Skive (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04183374
• Collaborator: (none)
• Enrollment: 680
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 41.9
• Patients Per Site Per Month: 16.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Life style	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 680 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: DNA Damage and Subfertility in Males - Lifestyle Interventions to Improve Male Fertility and Health
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation	Other: Life style; Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation

Outcome Measures

Primary Outcome Measures

1. Change in DNA fragmentation index (DFI) [3-4 months after inclusion]

   DFI is measured by SCSA

Secondary Outcome Measures

1. Change in classical sperm parameters [3-4 months after inclusion]

   Sperm count

2. Change in classical sperm parameters [3-4 months after inclusion]

   Sperm motility (movement)

3. Change in classical sperm parameters [3-4 months after inclusion]

   Sperm morphology (structure)

4. Change in classical sperm parameters [3-4 months after inclusion]

   Sperm concentration in mio sperm pr. milliliter

5. Changes in parameters for metabolic syndrome [3-4 months after inclusion]

   Weight in kilograms

6. Changes in parameters for metabolic syndrome [3-4 months after inclusion]

   Blood pressure in millimeters of mercury

7. Changes in parameters for metabolic syndrome [3-4 months after inclusion]

   Hemoglobin A1c in mmol/L

8. Changes in parameters for metabolic syndrome [3-4 months after inclusion]

   Body mass index in kg/m^2

9. Change in plasma lipids [3-4 months after inclusion]

   Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides

10. Change in serum D-vitamin levels [3-4 months after inclusion]

    25-hydroxy vitamin D (D3+D2) measured as nmol/l

11. Number of participants achieving live birth [Week 30-42 of pregnancy]

    Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.

12. Number of participants with clinical pregnancy [Week 7-8 of pregnancy]

    Measurement of heart beat by ultrasound scan

13. Number of participants with biochemical pregnancy [Day 14-17 of pregnancy]

    Increase in serum hCG levels

14. Cumulative live birth rate [9-24 months after inclusion]

    Live births originating from one controlled stimulation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• DNA fragmentation index above 15 %

Exclusion Criteria:

• TESA/PESA

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fertility Clinic Skive, Skive Regional Hospital	Skive		Denmark	7800

Sponsors and Collaborators

• Regionshospitalet Viborg, Skive

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Humaidan, Professor, Regionshospitalet Viborg, Skive
• ClinicalTrials.gov Identifier: NCT04183374
• Other Study ID Numbers: DFI2019Skiveintervention
• First Posted: Dec 3, 2019
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter Humaidan, Professor, Regionshospitalet Viborg, Skive: male infertility; DNA fragmentation Index; DFI; life style intervention
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Apr 5, 2022