Improved Fertility After Exercise in Overweight/Obese Women (FertilEX)

August 13, 2018 updated by: Norwegian University of Science and Technology

Study of Pregnancy Rate After Exercise Training Prior to Assisted Fertilisation in Overweight/Obese Women

Overweight/obesity is associated with sub-fertility. The investigators will assess if regular exercise training prior to assisted fertilization will improve pregnancy rate in overweight/obese women referred to assisted fertilization. It is expected that training will be successful in increasing pregnancy rate

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Obesity is associated with several diseases, as type 2 diabetes, cardiovascular disease and some types of cancer, this is of great concern for the public health. Also, of more immediate importance for these women; obesity is associated with increased risks of sub-fertility. The overall aim of the current project is to expand the knowledge about effective interventions to prevent the increasing prevalence of obesity-associated sub-fertility in population.

One cause of the increased referral rate for in-vitro fertilization is the growing prevalence of overweight and obesity. Currently, about 700 couples are annually referred for in-vitro fertilization at St.Olav's Hospital. In this interdisciplinary trial, involving physiotherapists, exercise physiologists, gynecologists, and basic researchers, the effects of regular high intensity exercise training on fertility in sub-fertile overweight and obese women will be investigated.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

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
      • Trondheim, Norway
        • St Olavs hospital
      • Ålesund, Norway
        • Ålesund Hospital

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 to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • body mass index (weight in kg/height in cm squared) >25
  • accepted for assisted fertilization treatment at St.Olav's hospital

Exclusion Criteria:

  • low responders, defined as AMH <2 pmol/L or < 5 oocytes in prior in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) cycles or antral follicle count (AFC) < 5
  • current or previous Metformin use (a wash-out period of > four weeks)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard care
Experimental: Exercise
Regular exercise training for 10 weeks prior to assisted fertilisation
Behavioral: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 7 weeks after assisted fertilisation
The primary outcome measure is ongoing pregnancy, defined as the sonographic evidence of intrauterine gestational sac and fetal heart activity at seven weeks of gestation.
7 weeks after assisted fertilisation

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Alesund Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FertilEX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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