NCT00934765

Brief 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

April 21, 2015

Status Verified

March 1, 2014

Enrollment Period

7.8 years

First QC Date

July 7, 2009

Last Update Submit

April 20, 2015

Conditions

OverweightObesity

Keywords

overweight, obesity, male, fertility

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • genetic variations in genes involved in metabolism and reproduction

    no time frame

Interventions

weight lossBEHAVIORAL

self-directed weight loss, guided weight loss, weight loss by gastric by-pass surgery

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age \> 18
  • BMI \> 27 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University College

Oslo, N-0130, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, semen

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Trine B. Haugen, PhD

    Oslo University College

    STUDY CHAIR

  • Oliwia Witczak, PhD

    Oslo University College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Trine B. Haugen, PhD

CONTACT

+47 22453023Trine.B.Haugen@hioa.no

Oliwia Witczak, PhD

CONTACT

+ 4722452347Oliwia.Witczak@hioa.no

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 8, 2009

Study Start

September 1, 2008

Primary Completion

June 1, 2016

Last Updated

April 21, 2015

Record last verified: 2014-03

Locations

NO(1)