Clinical trial NCT01933633: Improved Fertility After Exercise in Overweight/Obese Women
Official title: Study of Pregnancy Rate After Exercise Training Prior to Assisted Fertilisation in Overweight/Obese Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Infertility, Female
Keywords: Pregnancy
Fertility
exercise
Fertilization in vitro
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Alesund Hospital
First posted: 2013-09-02
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pregnancy rate
timeFrame: 7 weeks after assisted fertilisation
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trine Moholdt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lundgren KM, Romundstad LB, von During V, Morkved S, Kjotrod 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.
citation: Kiel IA, Lundgren KM, Morkved S, Kjotrod SB, Salvesen O, 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: 10.1136/bmjsem-2018-000387. eCollection 2018.