Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women (OF)

February 1, 2023 updated by: Jean-Patrice Baillargeon, Université de Sherbrooke

"Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"

BACKGROUND: Obesity increases the risk of polycystic ovary syndrome (PCOS), characterized by anovulatory cycles, but it is also associated with reduced fertility even in ovulatory women. Moreover, obesity increases the costs of assisted human reproduction (AHR) treatments and reduces their efficacy. In addition to fertility disorders, obesity increases significantly the risks of many complications of pregnancy, delivery and neonatal health. However, a modest loss of 5-10% of total body weight can restore ovulation and improve pregnancy rates.

OBJECTIVES: 1) To design and implement a multidisciplinary program for lifestyle management of obese women, or overweight women with PCOS, who seek fertility treatment in a secondary AHR center. 2) To evaluate lifestyle benefits of this program and assess its impact on fertility, pregnancy and neonatal outcomes, as compared to a randomly assigned control group and to similar women seen in tertiary AHR centers. 3) To assess cost per live birth, and other measures of cost-effectiveness, of this program compared to the control group and tertiary AHR centers. 4) To effectively transfer knowledge obtained through these activities to relevant stakeholders in the health care and public health sectors.

METHODS AND APPROACH: In order to design the program for lifestyle management of obesity in infertile women, we will gather a Committee composed of members of our interdisciplinary research team and relevant collaborators. Objectives 2 and 3 - In order to achieve these objectives, 128 obese women (BMI ≥ 30 kg/m²), or overweight women with PCOS (BMI ≥ 27 kg/m²), consulting at the CHUS fertility clinic will be randomized to our lifestyle program, and will suspend fertility treatments for six months, or to standard fertility treatments, which are directly initiated. The results obtained will also be compared to those of women with the same criteria who will consult in 3 tertiary AHR clinics not offering a similar lifestyle management program.

IMPACT: This project is very important as it will generate new knowledge about the implementation, impacts and costs of a new lifestyle management program in obese infertile women. Our project will obtain valuable data on implementability of such a program; on benefits with regard to lifestyle, fertility and maternal and foetal complications during pregnancy; as well as on reduction in cost per live birth and other cost-effectiveness ratio.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Obese (BMI ≥ 30kg/m2) infertile women
  • Overweight (BMI ≥ 27kg/m2) infertile women with polycystic ovary syndrome

Exclusion Criteria:

  • Women older than 40 years old
  • Women who went through bariatric surgery
  • Women under IVF
  • Women for whome IVF is the only recommended treatment
  • Women who do not speak french

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counseling
Behavioral: Interdisciplinary lifestyle intervention

Individual meetings with a dietitian and a kinesiologist at 0, 3, 6 weeks and then every 6 weeks for 18 months or until delivery. A reminder phone call/email will also take place once between each meeting.

The program also includes 12 group sessions discussing subjects about nutrition, psychology and demonstration of physical activity.

Other Names:
  • Lifestyle program for obese infertile women
No Intervention: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rates of live birth
Time Frame: Participants who will become pregnant: for the duration before they get pregnant and up to the end of pregnancy, an expected average of 18 months. Participants who will not become pregnant: 18 months
Participants who will become pregnant: for the duration before they get pregnant and up to the end of pregnancy, an expected average of 18 months. Participants who will not become pregnant: 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertility outcomes
Time Frame: 18 months
18 months
Pregnancy outcomes
Time Frame: Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study
Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study
Neonatal outcomes
Time Frame: Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study
Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study
Clinical outcomes
Time Frame: 18 months
Evolution of anthropometric measures, change in lifestyle habits, physical fitness level and evolution of readiness for change.
18 months
Cost per life birth, and other measures of cost-effectiveness
Time Frame: Participants who will become pregnant: for the duration before they get pregnant and up to the end of pregnancy, an expected average of 18 months. Participants who will not become pregnant: 18 months
All costs (interventions and complications) to achieve one life birth, including either all women with a life birth or all enrolled women (by intervention arm).
Participants who will become pregnant: for the duration before they get pregnant and up to the end of pregnancy, an expected average of 18 months. Participants who will not become pregnant: 18 months
Clinical outcomes in male partners
Time Frame: 18 months
Evolution of anthropometric measures and change in lifestyle habits in male partners.
18 months
Clinical outcomes of female participants
Time Frame: 18 months
Evolution of anthropometric measures, changes in lifestyle habits (diet, exercise, alcohol, tobacco), physical fitness level, evolution of readiness for change, etc.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux

Investigators

  • Principal Investigator: Jean-Patrice Baillargeon, MD, Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2012

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 25, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHR/FRN-114125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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