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

Not Applicable

Completed

• Conditions: Infertility; Obesity
• Interventions: Dietary Supplement: Low calorie diet treatment

• Registration Number: NCT01566929
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-30
• Primary Completion: 2016-01
• Study Completion: 2018-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 317

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight reduction treatment and IVF	Low calorie diet treatment	Dietary Supplement: Low calorie diet treatment and then IVFtreatment

Primary Outcome Measures

Name	Time	Method
Live birth	Approximately 10-16 months after randomization, depending on study group.	Live birth per participating woman

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Holbaek hospital; 🇩🇰 Holbaek, Denmark

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

ART Medica; 🇮🇸 Reykjavik, Iceland

Skånes Universitetssjukhus; 🇸🇪 Malmö, Sweden

Herlev hospital; 🇩🇰 Copenhagen, Denmark

Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden

Hvidovre hospital; 🇩🇰 Copenhagen, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Örebro University Hospital; 🇸🇪 Örebro, Sweden