Improved Fertility After Exercise in Overweight/Obese Women

NCT ID: NCT01933633

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Regular exercise training for 10 weeks prior to assisted fertilisation

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Trine Moholdt, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Ă…lesund Hospital

Ă…lesund, , Norway

Site Status

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 27250851 (View on PubMed)

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.

Reference Type RESULT
PMID: 30057778 (View on PubMed)

Other Identifiers

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FertilEX

Identifier Type: -

Identifier Source: org_study_id

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