Effect of Weight Loss on Reproductive Function in Overweight Men

April 20, 2015 updated by: Oliwia Witczak, Oslo University College

Effect of Weight Loss on Reproductive Function in Overweight Men.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, N-0130
        • Recruiting
        • Oslo University College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Oliwia Witczak, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Obese and overweight men that are planing to loss weight by diet and/or lifestyle changes or gastric by-pass surgery.

Description

Inclusion Criteria:

  • Age > 18
  • BMI > 27 kg/m2

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: minimum three months
minimum three months

Secondary Outcome Measures

Outcome Measure
Time Frame
genetic variations in genes involved in metabolism and reproduction
Time Frame: no time frame
no time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University College

Collaborators

Oslo University Hospital
The Hospital of Vestfold
Tartu University Hospital

Investigators

  • Study Chair: Trine B. Haugen, PhD, Oslo University College
  • Principal Investigator: Oliwia Witczak, PhD, Oslo University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiO 08/220b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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