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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01933633
Recruitment Status : Terminated (Enrollment proceeded to slowly)
First Posted : September 2, 2013
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
St. Olavs Hospital
Alesund Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Obesity Infertility, Female Behavioral: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Pregnancy Rate After Exercise Training Prior to Assisted Fertilisation in Overweight/Obese Women
Actual Study Start Date : September 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arm Intervention/treatment
Experimental: Exercise
Regular exercise training for 10 weeks prior to assisted fertilisation
Behavioral: Exercise
No Intervention: Control
Standard care



Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 7 weeks after assisted fertilisation ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933633


Locations
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Norway
St Olavs Hospital
Trondheim, Norway
Ålesund Hospital
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Alesund Hospital
Investigators
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Principal Investigator: Trine Moholdt, PhD Norwegian University of Science and Technology
Publications of Results:
Other Publications:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01933633    
Other Study ID Numbers: FertilEX
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Pregnancy
Fertility
exercise
Fertilization in vitro
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Overweight
Body Weight