COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)

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. Identifier: NCT01566929
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : September 7, 2018
Karolinska University Hospital
Skane University Hospital
Region Örebro County
Rigshospitalet, Denmark
Hvidovre University Hospital
Herlev Hospital
Holbaek Sygehus
ART Medica clinic, Iceland
Information provided by (Responsible Party):
Ann Thurin Kjellberg, Sahlgrenska University Hospital, Sweden

Brief Summary:
The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.

Condition or disease Intervention/treatment Phase
Infertility Obesity Dietary Supplement: Low calorie diet treatment Not Applicable

Detailed Description:
  1. There will be two groups of patients.

    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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Weight Management Interventions for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF): a Randomized Controlled Trial
Actual Study Start Date : October 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
No Intervention: IVF only
Active Comparator: Weight reduction treatment and IVF
Dietary Supplement: Low calorie diet treatment and then IVFtreatment
Dietary Supplement: Low calorie diet treatment
Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks

Primary Outcome Measures :
  1. Live birth [ Time Frame: Approximately 10-16 months after randomization, depending on study group. ]
    Live birth per participating woman

Secondary Outcome Measures :
  1. embryology [ Time Frame: After theIVF-treatment, approximately 1-6 months after randomization ]
    number of good quality embryos

  2. obstetric outcomes [ Time Frame: Approximately 10-16 months after randomization, after delivery ]
    obstetric and neonatal data

  3. compliance to intervention [ Time Frame: Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment ]
    Compliance to intervention assessed as weight loss during intervention, dietary intake and quality of life

  4. Husband data [ Time Frame: before IVF-treatment ]
    Measurement of the husband for height, weight and dietary intake and eating patterns correlated to sperm count, sperm motility and sperm chromatin fragmentation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria

  • Indication for IVF/ICSI for the couple
  • 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:

  • Diabetes mellitus treated with insulin
  • 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

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 identifier (NCT number): NCT01566929

Layout table for location information
Herlev hospital
Copenhagen, Denmark
Hvidovre hospital
Copenhagen, Denmark
Copenhagen, Denmark
Holbaek hospital
Holbaek, Denmark
ART Medica
Reykjavik, Iceland
Sahlgrenska University Hospital
Göteborg, Sweden
Skånes Universitetssjukhus
Malmö, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Örebro University Hospital
Örebro, Sweden
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
Skane University Hospital
Region Örebro County
Rigshospitalet, Denmark
Hvidovre University Hospital
Herlev Hospital
Holbaek Sygehus
ART Medica clinic, Iceland
Layout table for investigator information
Principal Investigator: Ann Thurin Kjellberg, MD PhD Sahlgrenska University Hospital, Sweden

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ann Thurin Kjellberg, MD, PhD, Sahlgrenska University Hospital, Sweden Identifier: NCT01566929    
Other Study ID Numbers: Obesity/IVF
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Keywords provided by Ann Thurin Kjellberg, Sahlgrenska University Hospital, Sweden:
In vitro fertilization
Low calorie diet (LCD)
Obstetric outcome
Weight reduction
Additional relevant MeSH terms:
Layout table for MeSH terms
Genital Diseases, Male
Genital Diseases, Female