The Effect of a Multimodal Lifestyle Program on Male Fertility

• Sponsor: Peter Humaidan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04761250
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male	Dietary Supplement: Lifestyle	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment
• Actual Study Start Date: Feb 15, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Increase in the total amount of motil sperm in male patients undergoing fertility treatment [90 days]

   Change in classical sperm parameters

Secondary Outcome Measures

1. Change in DNA fragmentation index (DFI) [90 days]

   DFI is measured by Comet Assay

2. Changes in parameters for metabolic syndrome [90 days]

   Weight in kilograms

3. Changes in parameters for metabolic syndrome [90 days]

   BMI (Body Mass Index). Weight and height will be combined to report BMI in kg/m^2

4. Changes in parameters for metabolic syndrome [90 days]

   Blood pressure in millimeters of mercury

5. Change in plasma lipids [90 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Peter Humaidan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Humaidan, Professor, Consultant, Regionshospitalet Viborg, Skive
• ClinicalTrials.gov Identifier: NCT04761250
• Other Study ID Numbers: 1-10-72-109-20
• First Posted: Feb 18, 2021
• 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, Consultant, Regionshospitalet Viborg, Skive: Male infertility; Semen quality; Lifestyle intervention
• Additional relevant MeSH terms: Infertility; Infertility, Male

Study Results

No Results Posted as of Apr 5, 2022