Effect of Weight Loss on Reproductive Function in Overwei... | NCT00934765

Studies
Effect of Weight Loss on Reproductive Function in Overweight Men

NCT00934765

Sponsor

Oslo University College

Status

Unknown status

Last Update Posted

Apr 21, 2015Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Overweight
Obesity

Interventions

weight loss

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jun 2016Estimated

Completion Date

Not provided

First Submitted Date

Jul 7, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2015

Last Update Posted Date

Apr 21, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oliwia Witczak, associate professor, Oslo Metropolitan UniversityPrincipal Investigator

Lead Sponsor

Oslo University CollegeOTHER

Collaborators

Name	Class
Oslo University Hospital	OTHER
The Hospital of Vestfold	OTHER
Tartu University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
weight loss	Behavioral	self-directed weight loss, guided weight loss, weight loss by gastric by-pass surgery

Outcomes Module

Primary Outcomes

Measure	Description	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		minimum three months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18
BMI > 27 kg/m2

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Trine B. Haugen, PhD	Contact	+47 22453023		Trine.B.Haugen@hioa.no
Oliwia Witczak, PhD	Contact	+ 4722452347		Oliwia.Witczak@hioa.no

Overall Officials

Name	Affiliation	Role
Trine B. Haugen, PhD	Oslo University College	Study Chair
Oliwia Witczak, PhD	Oslo University College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University College	Recruiting	Oslo		N-0130	Norway

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided