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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sahlgrenska University Hospital, Sweden
Sponsor:
Collaborators:
Karolinska University Hospital
Skåne University Hospital
University Hospital Orebro
Rigshospitalet, Denmark
Hvidovre hospital, Denmark
Herlev Hospital, Denmark
Holbaek Hospital, Denmark
ART Medica clinic, Iceland
Information provided by (Responsible Party):
Ann Thurin Kjellberg, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01566929
First received: March 23, 2012
Last updated: November 20, 2014
Last verified: November 2014

March 23, 2012
November 20, 2014
October 2010
December 2015   (final data collection date for primary outcome measure)
Live birth [ Time Frame: Approximately 10-16 months after randomization, depending on study group. ] [ Designated as safety issue: No ]
Live birth per participating woman
Same as current
Complete list of historical versions of study NCT01566929 on ClinicalTrials.gov Archive Site
  • embryology [ Time Frame: After theIVF-treatment, approximately 1-6 months after randomization ] [ Designated as safety issue: No ]
    number of good quality embryos
  • obstetric outcomes [ Time Frame: Approximately 10-16 months after randomization, after delivery ] [ Designated as safety issue: No ]
    obstetric and neonatal data
  • compliance to intervention [ Time Frame: Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment ] [ Designated as safety issue: No ]
    Compliance to intervention assessed as weight loss during intervention, dietary intake and quality of life
  • Husband data [ Time Frame: before IVF-treatment ] [ Designated as safety issue: No ]
    Measurement of the husband for height, weight and dietary intake and eating patterns correlated to sperm count, sperm motility and sperm chromatin fragmentation
Same as current
Not Provided
Not Provided
 
Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)
Weight Management Interventions for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF): a Randomized Controlled Trial

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.

  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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Infertility
  • Obesity
Dietary Supplement: Low calorie diet treatment
Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks
  • No Intervention: IVF only
    IVFtreatment
  • Active Comparator: Weight reduction treatment and IVF
    Dietary Supplement: Low calorie diet treatment and then IVFtreatment
    Intervention: Dietary Supplement: Low calorie diet treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
334
December 2017
December 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 37 Years
No
Contact: Ann Thurin Kjellberg, MD, PhD +46 31 3429232 ann.thurin@vgregion.se
Contact: Linda Kluge, Midwife +46 708812214 linda.kluge@vgregion.se
Denmark,   Iceland,   Sweden
 
NCT01566929
Obesity/IVF
Yes
Ann Thurin Kjellberg, Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden
  • Karolinska University Hospital
  • Skåne University Hospital
  • University Hospital Orebro
  • Rigshospitalet, Denmark
  • Hvidovre hospital, Denmark
  • Herlev Hospital, Denmark
  • Holbaek Hospital, Denmark
  • ART Medica clinic, Iceland
Principal Investigator: Ann Thurin Kjellberg, MD PhD Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP