Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women (OF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01483612|
Recruitment Status : Active, not recruiting
First Posted : December 1, 2011
Last Update Posted : October 25, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Female Infertility Polycystic Ovary Syndrome Obesity||Behavioral: Interdisciplinary lifestyle intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||"Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
|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 Name: Lifestyle program for obese infertile women
|No Intervention: control|
- 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 ]
- 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 ]Evolution of anthropometric measures, change in lifestyle habits, physical fitness level and evolution of readiness for change.
- 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).
- Clinical outcomes in male partners [ Time Frame: 18 months ]Evolution of anthropometric measures and change in lifestyle habits in male partners.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483612
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Jean-Patrice Baillargeon, MD||Université de Sherbrooke|