Clinical trial NCT01566929: Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)
Official title: Weight Management Interventions for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Obesity
Keywords: Obesity
In vitro fertilization
Low calorie diet (LCD)
Obstetric outcome
Weight reduction
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Skane University Hospital
name: Region Örebro County
name: Rigshospitalet, Denmark
name: Hvidovre University Hospital
name: Herlev Hospital
name: Holbaek Sygehus
name: ART Medica clinic, Iceland
First posted: 2012-03-30
Enrollment: 317
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Live birth
timeFrame: Approximately 10-16 months after randomization, depending on study group.
Secondary outcomes:
measure: embryology
timeFrame: After theIVF-treatment, approximately 1-6 months after randomization
measure: obstetric outcomes
timeFrame: Approximately 10-16 months after randomization, after delivery
measure: compliance to intervention
timeFrame: Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment
measure: Husband data
timeFrame: before IVF-treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev hospital
city: Copenhagen
country: Denmark
facility: Hvidovre hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Holbaek
country: Denmark
facility: Holbaek hospital
city: Reykjavik
country: Iceland
facility: ART Medica
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Ann Thurin Kjellberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svensson H, Einarsson S, Olausson D, Kluge L, Bergh C, Eden S, Lonn M, Thurin-Kjellberg A. Inflammatory and metabolic markers in relation to outcome of in vitro fertilization in a cohort of predominantly overweight and obese women. Sci Rep. 2022 Aug 3;12(1):13331. doi: 10.1038/s41598-022-17612-2.
citation: Kluge L, Bergh C, Einarsson S, Pinborg A, Mikkelsen Englund AL, Thurin-Kjellberg A. Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. Hum Reprod Open. 2019 Dec 10;2019(4):hoz030. doi: 10.1093/hropen/hoz030. eCollection 2019.
citation: Einarsson S, Bergh C, Friberg B, Pinborg A, Klajnbard A, Karlstrom PO, Kluge L, Larsson I, Loft A, Mikkelsen-Englund AL, Stenlof K, Wistrand A, Thurin-Kjellberg A. Weight reduction intervention for obese infertile women prior to IVF: a randomized controlled trial. Hum Reprod. 2017 Aug 1;32(8):1621-1630. doi: 10.1093/humrep/dex235.