Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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There will be two groups of patients.
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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.
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: IVF only IVFtreatment |
|
| Active Comparator: Weight reduction treatment and IVF Dietary Supplement: Low calorie diet treatment and then IVFtreatment |
Dietary Supplement: Low calorie diet treatment
Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Live birth [Approximately 10-16 months after randomization, depending on study group.]
Live birth per participating woman
Secondary Outcome Measures
- embryology [After theIVF-treatment, approximately 1-6 months after randomization]
number of good quality embryos
- 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
Eligibility Criteria
Criteria
Inclusion criteria
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Indication for IVF/ICSI for the couple
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Woman's age >18< 38 years at randomization
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First, second or third IVF/ICSI treatment
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BMI > or = 30.0 <35.0 kg/m2
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Willing to participate and to sign informed consent
Exclusion Criteria:
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Diabetes mellitus treated with insulin
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Oocyte or sperm donation planned
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Preimplantation genetic diagnosis (PGD) treatment planned
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Azoospermia known at randomization
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Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires)
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QEWP-R questionnaire indicating binge eating disorder for the woman
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Previous participation in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev hospital | Copenhagen | Denmark | ||
| 2 | Hvidovre hospital | Copenhagen | Denmark | ||
| 3 | Rigshospitalet | Copenhagen | Denmark | ||
| 4 | Holbaek hospital | Holbaek | Denmark | ||
| 5 | ART Medica | Reykjavik | Iceland | ||
| 6 | Sahlgrenska University Hospital | Göteborg | Sweden | ||
| 7 | Skånes Universitetssjukhus | Malmö | Sweden | ||
| 8 | Karolinska Universitetssjukhuset | Stockholm | Sweden | ||
| 9 | Örebro University Hospital | Örebro | Sweden |
Sponsors and Collaborators
- Sahlgrenska University Hospital, Sweden
- Karolinska University Hospital
- Skane University Hospital
- Region Örebro County
- Rigshospitalet, Denmark
- Hvidovre University Hospital
- Herlev Hospital
- Holbaek Sygehus
- ART Medica clinic, Iceland
Investigators
- Principal Investigator: Ann Thurin Kjellberg, MD PhD, Sahlgrenska University Hospital, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Obesity/IVF