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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Infertility
• Intervention / Treatment: Dietary supplement: Low calorie diet treatment

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 Type: Interventional
• Enrollment (Actual): 317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
  • Copenhagen, Denmark
    • Herlev Hospital
  • Copenhagen, Denmark
    • Hvidovre Hospital
  • Holbaek, Denmark
    • Holbaek Hospital
• Iceland
  • Reykjavik, Iceland
    • ART Medica
• Sweden
  • Göteborg, Sweden
    • Sahlgrenska University Hospital
  • Malmö, Sweden
    • Skånes universitetssjukhus
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset
  • Örebro, Sweden
    • Orebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Karolinska University Hospital; Rigshospitalet, Denmark; Hvidovre University Hospital; Herlev Hospital; Holbaek Sygehus; Skane University Hospital; Region Örebro County; ART Medica clinic, Iceland
• Investigators: Principal Investigator: Ann Thurin Kjellberg, MD PhD, Sahlgrenska University Hospital, Sweden

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 30, 2012

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; In vitro fertilization; Weight reduction; Obstetric outcome; Low calorie diet (LCD)
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Obesity/IVF