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 September 2013 by Sahlgrenska University Hospital, Sweden
Sponsor:
Collaborators:
Karolinska University Hospital
Skåne University Hospital
University Hospital Orebro
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Ann Thurin Kjellberg, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01566929
First received: March 23, 2012
Last updated: September 21, 2013
Last verified: September 2013
  Purpose

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 Intervention
Infertility
Obesity
Dietary Supplement: Low calorie diet treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Live birth [ Time Frame: Approximately 10-16 months after randomization, depending on study group. ] [ Designated as safety issue: No ]
    Live birth per participating woman


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 334
Study Start Date: October 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: IVF only
Active Comparator: Weight reduction treatment and IVF Dietary Supplement: Low calorie diet treatment
Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks

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.
  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566929

Contacts
Contact: Ann Thurin Kjellberg, MD, PhD +46 31 3429232 ann.thurin@vgregion.se
Contact: Snorri Einarsson, MD +46 31 3423212 snorri.einarsson@vgregion.se

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Anne Loft, MD PhD         
Principal Investigator: Anne Loft, MD PhD         
Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden
Contact: Ann Thurin Kjellberg, MD PhD    +46 31 3423292    ann.thurin@vgregion.se   
Principal Investigator: Ann Thurin Kjellberg, MD PhD         
Skånes Universitetssjukhus Recruiting
Malmö, Sweden
Contact: Britt Friberg, MD PhD         
Principal Investigator: Britt Friberg, MD PhD         
Karolinska Universitetssjukhuset Recruiting
Stockholm, Sweden
Contact: Per-Olof Karlström, MD PhD         
Principal Investigator: Per-Olof Karlström, MD PhD         
Örebro University Hospital Recruiting
Örebro, Sweden
Contact: Mikael Lood, MD         
Principal Investigator: Mikael Lood, MD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
Skåne University Hospital
University Hospital Orebro
Rigshospitalet, Denmark
Investigators
Principal Investigator: Ann Thurin Kjellberg, MD PhD Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Ann Thurin Kjellberg, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01566929     History of Changes
Other Study ID Numbers: Obesity/IVF
Study First Received: March 23, 2012
Last Updated: September 21, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Sahlgrenska University Hospital, Sweden:
Obesity
In vitro fertilization
Low calorie diet (LCD)
Obstetric outcome
Weight reduction

Additional relevant MeSH terms:
Infertility
Obesity
Genital Diseases, Male
Genital Diseases, Female
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014