Overview

This trial is active, not recruiting.

Conditions female infertility, polycystic ovary syndrome, obesity
Treatment interdisciplinary lifestyle intervention
Sponsor Université de Sherbrooke
Collaborator Canadian Institutes of Health Research (CIHR)
Start date November 2011
End date June 2016
Trial size 128 participants
Trial identifier NCT01483612, CIHR/FRN-114125

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
interdisciplinary lifestyle intervention Lifestyle program for obese infertile women
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.
(No Intervention)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Fertility outcomes
time frame: 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
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
Clinical outcomes
time frame: 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
Clinical outcomes in male partners
time frame: 18 months
Clinical outcomes of female participants
time frame: 18 months

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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

Additional Information

Official title "Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"
Principal investigator Jean-Patrice Baillargeon, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Université de Sherbrooke.