Effect of Weight Loss on Reproductive Function in Overweight Men

Obesity Clinical Trial

Official title:

Effect of Weight Loss on Reproductive Function in Overweight Men.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00934765
• Other study ID #: HiO 08/220b
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2009
• Last updated: April 20, 2015
• Start date: September 2008

Study information

• Verified date: March 2014
• Source: Oslo University College
• Contact: Trine B. Haugen, PhD
• Phone: +47 22453023
• Email: Trine.B.Haugen[@]hioa.no
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

Obesity has been found to be a risk factor for female infertility. Studies have indicated that obese men often have poor semen quality and require increased time to make partner pregnant. To date, no studies have investigated the effect of weight reduction on male fertility. The purpose of this study is to investigate the effect of weight reduction in overweight and obese men on their reproductive function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• BMI > 27 kg/m2

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• weight loss
self-directed weight loss, guided weight loss, weight loss by gastric by-pass surgery

Locations

Country	Name	City	State
Norway	Oslo University College	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University College	Oslo University Hospital, Tartu University Hospital, The Hospital of Vestfold

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight, height, % body fat, sperm (volume, concentration, motility, morphology, vitality), sperm DNA integrity, steroid hormones, gonadotropins, blood glucose, HbA1c, mCRP, lipids, adiponectins, fatty acid composition in serum and sperm phospholipids		minimum three months	No
Secondary	genetic variations in genes involved in metabolism and reproduction		no time frame	No