Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)
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.
|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|
- Live birth [ Time Frame: Approximately 10-16 months after randomization, depending on study group. ] [ Designated as safety issue: No ]Live birth per participating woman
- 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
|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)|
|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
There will be two groups of patients.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566929
|Contact: Ann Thurin Kjellberg, MD, PhD||+46 31 firstname.lastname@example.org|
|Contact: Snorri Einarsson, MD||+46 31 email@example.com|
|Contact: Anne Loft, MD PhD|
|Principal Investigator: Anne Loft, MD PhD|
|Sahlgrenska University Hospital||Recruiting|
|Contact: Ann Thurin Kjellberg, MD PhD +46 31 3423292 firstname.lastname@example.org|
|Principal Investigator: Ann Thurin Kjellberg, MD PhD|
|Contact: Britt Friberg, MD PhD|
|Principal Investigator: Britt Friberg, MD PhD|
|Contact: Per-Olof Karlström, MD PhD|
|Principal Investigator: Per-Olof Karlström, MD PhD|
|Örebro University Hospital||Recruiting|
|Contact: Mikael Lood, MD|
|Principal Investigator: Mikael Lood, MD|
|Principal Investigator:||Ann Thurin Kjellberg, MD PhD||Sahlgrenska University Hospital, Sweden|