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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Weight Management Interventions for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF): a Randomized Controlled Trial

Conditions
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Infertility, Obesity

Intervention / Treatment
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* Dietary Supplement: Low calorie diet treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: IVF only<br>IVFtreatment | |
| Active Comparator: Weight reduction treatment and IVF<br>Dietary Supplement: Low calorie diet treatment and then IVFtreatment | Dietary Supplement: Low calorie diet treatment<br>* Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth | Live birth per participating woman | Approximately 10-16 months after randomization, depending on study group. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryology | number of good quality embryos | After theIVF-treatment, approximately 1-6 months after randomization | 
| obstetric outcomes | obstetric and neonatal data | Approximately 10-16 months after randomization, after delivery | 
| compliance to intervention | Compliance to intervention assessed as weight loss during intervention, dietary intake and quality of life | Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment | 
| Husband data | Measurement of the husband for height, weight and dietary intake and eating patterns correlated to sperm count, sperm motility and sperm chromatin fragmentation | before IVF-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, In vitro fertilization, Low calorie diet (LCD), Obstetric outcome, Weight reduction