NCT01566929

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

5.3 years

First QC Date

March 23, 2012

Last Update Submit

September 5, 2018

Conditions

InfertilityObesity

Keywords

ObesityIn vitro fertilizationLow calorie diet (LCD)Obstetric outcomeWeight reduction

Outcome Measures

Primary Outcomes (1)

  • Live birth

    Live birth per participating woman

    Approximately 10-16 months after randomization, depending on study group.

Secondary Outcomes (4)

  • embryology

    After theIVF-treatment, approximately 1-6 months after randomization

  • obstetric outcomes

    Approximately 10-16 months after randomization, after delivery

  • compliance to intervention

    Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment

  • Husband data

    before IVF-treatment

Study Arms (2)

IVF only

NO INTERVENTION

IVFtreatment

Weight reduction treatment and IVF

ACTIVE COMPARATOR

Dietary Supplement: Low calorie diet treatment and then IVFtreatment

Dietary Supplement: Low calorie diet treatment

Interventions

Low calorie diet treatmentDIETARY_SUPPLEMENT

Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks

Weight reduction treatment and IVF

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Herlev hospital

Copenhagen, Denmark

Location

Hvidovre hospital

Copenhagen, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Holbaek hospital

Holbæk, Denmark

Location

ART Medica

Reykjavik, Iceland

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Skånes Universitetssjukhus

Malmo, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 35922472DERIVED

  • 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.

    PMID: 31844684DERIVED

  • 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.

    PMID: 28854592DERIVED

MeSH Terms

Conditions

InfertilityObesityWeight Loss

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Ann Thurin Kjellberg, MD PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 23, 2012

First Posted

March 30, 2012

Study Start

October 1, 2010

Primary Completion

January 1, 2016

Study Completion

April 1, 2018

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

IC(1)DK(4)SE(4)