Improved Fertility After Exercise in Overweight/Obese Women

NCT01933633 | Terminated

• 1 other identifier: FertilEX
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Conditions

Obesity; Infertility, Female

Keywords

Pregnancy; Fertility; exercise; Fertilization in vitro

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Exercise

EXPERIMENTAL

Regular exercise training for 10 weeks prior to assisted fertilisation

Behavioral: Exercise

Control

NO INTERVENTION

Standard care

Interventions

Exercise BEHAVIORAL

Exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index (weight in kg/height in cm squared) \>25
• accepted for assisted fertilization treatment at St.Olav's hospital

You may not qualify if:

• 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)

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Alesund Hospital: collaborator

Study Sites (2)

Ålesund Hospital

Ålesund, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

• 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.

  PMID: 27250851 BACKGROUND

• 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.

  PMID: 30057778 RESULT

MeSH Terms

Conditions

Obesity; Infertility, Female; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Trine Moholdt, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

NO (2)