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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborators:
St. Olavs Hospital
Alesund Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01933633
First received: August 28, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Obesity
Infertility, Female
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Pregnancy Rate After Exercise Training Prior to Assisted Fertilisation in Overweight/Obese Women

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 7 weeks after assisted fertilisation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 140
Study Start Date: September 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
Regular exercise training for 10 weeks prior to assisted fertilisation
Behavioral: Exercise
No Intervention: Control
Standard care

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933633

Contacts
Contact: Trine Moholdt, PhD 0047 97098594 trine.moholdt@ntnu.no
Contact: Kari M Lundgren kari.m.lundgren@ntnu.no

Locations
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Ålesund Hospital Recruiting
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Alesund Hospital
Investigators
Principal Investigator: Trine Moholdt, PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01933633     History of Changes
Other Study ID Numbers: FertilEX
Study First Received: August 28, 2013
Last Updated: May 23, 2014
Health Authority: Norway: Ethics Committee

Keywords provided by Norwegian University of Science and Technology:
Pregnancy
Fertility
exercise
Fertilization in vitro

Additional relevant MeSH terms:
Overweight
Infertility
Infertility, Female
Body Weight
Signs and Symptoms
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 02, 2014