Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)
NCT ID: NCT01566929
Last Updated: 2018-09-07
Study Results
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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COMPLETED
NA
317 participants
INTERVENTIONAL
2010-10-31
2018-04-30
Brief Summary
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Detailed Description
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1. The first group (n=167) will receive weight management intervention during up to four months prior to IVF treatment.The group randomized to intervention will start an intensive weight reduction plan. The aim of the weight reduction is to reach as close to normal BMI (\<25.0 kg/m2) as possible during a time of approximately 4 months. The purpose of the dietary intervention is to create a negative energy balance to induce weight loss. The intervention starts with 12 weeks of a low calorie liquid formula diet (LCD) and thereafter, diet re-introduction and weight control stabilization until IVF treatment begins. Should the patient for some reason be unable to fulfil the LCD-treatment, she will anyhow have an individualized dietary counselling to help her loose weight until the time for her IVF-treatment.
2. The second group (n=167) will start their IVF-treatment directly without other intervention than written advice about the benefits of weight reduction and exercise. The group randomized directly to IVF-treatment will start the treatment as soon as possible after randomization, preferably within that menstrual cycle.
2. Tertiary aim is a follow-up 2 years after randomization to the study with questionnaires to the couple in both the intervention and the control groups. A special questionnaire will cover the weights of the couple and if the woman has had any pregnancies or live births after concluding the study. For the women having achieved a live birth in the index-cycle of IVF the number of children and also follow-up of the children will be performed by assessing medical records from pediatric clinic (if applicable) and child health care centres covering birth data, general health and weight of the children at birth and at the assessment date. Eating -habits and -patterns and quality of life parameters will be assessed with the same three questionnaires that were filled in after randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IVF only
IVFtreatment
No interventions assigned to this group
Weight reduction treatment and IVF
Dietary Supplement: Low calorie diet treatment and then IVFtreatment
Low calorie diet treatment
Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks
Interventions
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Low calorie diet treatment
Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Woman's age \>18\< 38 years at randomization
* First, second or third IVF/ICSI treatment
* BMI \> or = 30.0 \<35.0 kg/m2
* Willing to participate and to sign informed consent
Exclusion Criteria
* Oocyte or sperm donation planned
* Preimplantation genetic diagnosis (PGD) treatment planned
* Azoospermia known at randomization
* Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires)
* QEWP-R questionnaire indicating binge eating disorder for the woman
* Previous participation in the study
18 Years
37 Years
FEMALE
No
Sponsors
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Karolinska University Hospital
OTHER
Skane University Hospital
OTHER
Region Örebro County
OTHER
Rigshospitalet, Denmark
OTHER
Hvidovre University Hospital
OTHER
Herlev Hospital
OTHER
Holbaek Sygehus
OTHER
ART Medica clinic, Iceland
UNKNOWN
Sahlgrenska University Hospital
OTHER
Responsible Party
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Ann Thurin Kjellberg
MD, PhD
Principal Investigators
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Ann Thurin Kjellberg, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Herlev hospital
Copenhagen, , Denmark
Hvidovre hospital
Copenhagen, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Holbaek hospital
Holbæk, , Denmark
ART Medica
Reykjavik, , Iceland
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skånes Universitetssjukhus
Malmo, , Sweden
Örebro University Hospital
Örebro, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Countries
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References
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Svensson H, Einarsson S, Olausson D, Kluge L, Bergh C, Eden S, Lonn M, Thurin-Kjellberg A. Inflammatory and metabolic markers in relation to outcome of in vitro fertilization in a cohort of predominantly overweight and obese women. Sci Rep. 2022 Aug 3;12(1):13331. doi: 10.1038/s41598-022-17612-2.
Kluge L, Bergh C, Einarsson S, Pinborg A, Mikkelsen Englund AL, Thurin-Kjellberg A. Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. Hum Reprod Open. 2019 Dec 10;2019(4):hoz030. doi: 10.1093/hropen/hoz030. eCollection 2019.
Einarsson S, Bergh C, Friberg B, Pinborg A, Klajnbard A, Karlstrom PO, Kluge L, Larsson I, Loft A, Mikkelsen-Englund AL, Stenlof K, Wistrand A, Thurin-Kjellberg A. Weight reduction intervention for obese infertile women prior to IVF: a randomized controlled trial. Hum Reprod. 2017 Aug 1;32(8):1621-1630. doi: 10.1093/humrep/dex235.
Other Identifiers
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Obesity/IVF
Identifier Type: -
Identifier Source: org_study_id
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