Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)
Condition: Infertility; Obesity
MeSH terms: Infertility
Study type: Interventional

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.
    

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.
    

Intervention name(s): Low calorie diet treatment
Intervention type(s): Dietary Supplement
Intervention description(s): Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; In vitro fertilization; Low calorie diet (LCD); Obstetric outcome; Weight reduction