Improved Fertility After Exercise in Overweight/Obese Women

Obesity Clinical Trial

— FertilEX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01933633
• Other study ID #: FertilEX
• Status: Terminated
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Obesity
• Overweight

Intervention

Behavioral:
• Exercise

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Alesund Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Kiel IA, Lundgren KM, Mørkved S, Kjøtrød SB, Salvesen Ø, Romundstad LB, Moholdt T. Women undergoing assisted fertilisation and high-intensity interval training: a pilot randomised controlled trial. BMJ Open Sport Exerc Med. 2018 Jul 17;4(1):e000387. doi: — View Citation

Lundgren KM, Romundstad LB, von Düring V, Mørkved S, Kjøtrød S, Moholdt T. Exercise prior to assisted fertilization in overweight and obese women (FertilEX): study protocol for a randomized controlled trial. Trials. 2016 Jun 1;17(1):268. doi: 10.1186/s13063-016-1398-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	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