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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01933633
Other study ID # FertilEX
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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