Improved Fertility After Exercise in Overweight/Obese Women (FertilEX)
|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|
- 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.
|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)|
Regular exercise training for 10 weeks prior to assisted fertilisation
No Intervention: Control
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933633
|Contact: Trine Moholdt, PhD||0047 firstname.lastname@example.org|
|Contact: Kari M Lundgrenemail@example.com|
|St Olavs Hospital||Recruiting|
|Principal Investigator:||Trine Moholdt, PhD||Norwegian University of Science and Technology|