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Clinical Trials/NCT01933633
NCT01933633
Terminated
Not Applicable

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

Norwegian University of Science and Technology2 sites in 1 country18 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Norwegian University of Science and Technology
Enrollment
18
Locations
2
Primary Endpoint
Pregnancy rate
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

Study Sites (2)

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