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

NCT01483612 | Completed

• 1 other identifier: CIHR/FRN-114125
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Female Infertility; Polycystic Ovary Syndrome; Obesity

Keywords

Body Weight; Female; Infertility, Female/therapy; Infertility, Female/physiopathology; Obesity/physiopathology; Polycystic ovary syndrome; Pregnancy; Pregnancy Outcome; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Rates of live birth

  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 Outcomes (7)

• Fertility outcomes

  18 months

• Pregnancy outcomes

  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

  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

  18 months

• Cost per life birth, and other measures of cost-effectiveness

  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

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

Behavioral: Interdisciplinary lifestyle intervention

control

NO INTERVENTION

Interventions

Interdisciplinary lifestyle intervention BEHAVIORAL

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.

Also known as: Lifestyle program for obese infertile women

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Ministere de la Sante et des Services Sociaux: collaborator

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (2)

• St-Laurent A, Belan M, Jean-Denis F, Langlois MF, Pesant MH, Carranza-Mamane B, Duval K, Morisset AS, Baillargeon JP. An interdisciplinary intervention improves lifestyle behaviours in women living with obesity and subfertility: A secondary analysis of a randomized controlled trial. Clin Nutr ESPEN. 2025 Aug;68:457-464. doi: 10.1016/j.clnesp.2025.05.036. Epub 2025 May 28.

  PMID: 40447224 DERIVED

• Duval K, Langlois MF, Carranza-Mamane B, Pesant MH, Hivert MF, Poder TG, Lavoie HB, Ainmelk Y, St-Cyr Tribble D, Laredo S, Greenblatt E, Sagle M, Waddell G, Belisle S, Riverin D, Jean-Denis F, Belan M, Baillargeon JP. The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. BMC Obes. 2015 Dec 1;2:47. doi: 10.1186/s40608-015-0077-x. eCollection 2015.

  PMID: 26635965 DERIVED

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome; Obesity; Body Weight; Infertility; Weight Loss

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Jean-Patrice Baillargeon, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 25, 2011
• First Posted: December 1, 2011
• Study Start: January 20, 2012
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

CA (1)