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

Primary Purpose

Obesity, Infertility, Female

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Pregnancy, Fertility, exercise, Fertilization in vitro

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • St Olavs Hospital
  • Ålesund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Regular exercise training for 10 weeks prior to assisted fertilisation

Standard care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2013
Last Updated
August 13, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Alesund Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01933633
Brief Title
Improved Fertility After Exercise in Overweight/Obese Women
Acronym
FertilEX
Official Title
Study of Pregnancy Rate After Exercise Training Prior to Assisted Fertilisation in Overweight/Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Enrollment proceeded to slowly
Study Start Date
September 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Alesund Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Infertility, Female
Keywords
Pregnancy, Fertility, exercise, Fertilization in vitro

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Regular exercise training for 10 weeks prior to assisted fertilisation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
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.
Time Frame
7 weeks after assisted fertilisation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trine Moholdt, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
Ålesund Hospital
City
Ålesund
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27250851
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.
Results Reference
background
PubMed Identifier
30057778
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.
Results Reference
result

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Improved Fertility After Exercise in Overweight/Obese Women

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