- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00934765
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
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 Contact
- Name: Trine B. Haugen, PhD
- Phone Number: +47 22453023
- Email: Trine.B.Haugen@hioa.no
Study Contact Backup
- Name: Oliwia Witczak, PhD
- Phone Number: + 4722452347
- Email: Oliwia.Witczak@hioa.no
Study Locations
-
-
-
Oslo, Norway, N-0130
- Recruiting
- Oslo University College
-
Contact:
- Trine B. Haugen, PhD
- Phone Number: +47 45 3023
- Email: Trine.B.Haugen@hioa.no
-
Contact:
- Oliwia Witczak, PhD
- Phone Number: +47 67236277
- Email: Oliwia.Witczak@hioa.no
-
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
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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on weight loss
-
University of VermontUniversity of Vermont Medical CenterCompletedBreast Cancer | Overweight | PostmenopausalUnited States
-
University of PittsburghCompleted
-
University of Alabama at BirminghamNational Cancer Institute (NCI)Completed
-
VA Office of Research and DevelopmentTerminatedOverweight | Obstructive Sleep ApneaUnited States
-
University of TennesseeCompleted
-
Boston Children's HospitalUniversity of Alabama at Birmingham; Indiana University; Baylor University; Framingham...Terminated
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Maryland Cigarette Restitution FundCompletedKidney Cancer | Breast Cancer | Rectal Cancer | Prostate Cancer | Bladder Cancer | Endometrial Cancer | Melanoma (Skin) | Gallbladder CancerUnited States
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of Alabama at BirminghamCompletedCancer | Weight LossUnited States