Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women (OF)
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Purpose
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 | Intervention |
|---|---|
|
Female Infertility Polycystic Ovary Syndrome Obesity |
Behavioral: Interdisciplinary lifestyle intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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" |
- 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 ] [ Designated as safety issue: No ]
- Fertility outcomes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Clinical outcomes [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Evolution of anthropometric measures and change in lifestyle habits in male partners.
- Clinical outcomes of female participants [ Time Frame: 18 months ] [ Designated as safety issue: No ]Evolution of anthropometric measures, changes in lifestyle habits (diet, exercise, alcohol, tobacco), physical fitness level, evolution of readiness for change, etc.
| Estimated Enrollment: | 128 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01483612
| Canada, Quebec | |
| Centre hospitalier universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Principal Investigator: | Jean-Patrice Baillargeon, MD | Université de Sherbrooke |
More Information
| Responsible Party: | Jean-Patrice Baillargeon, Associate Professor, Université de Sherbrooke |
| ClinicalTrials.gov Identifier: | NCT01483612 History of Changes |
| Other Study ID Numbers: | CIHR/FRN-114125 |
| Study First Received: | November 25, 2011 |
| Last Updated: | June 29, 2015 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Université de Sherbrooke:
|
Body Weight Female Infertility, Female/therapy Infertility, Female/physiopathology Obesity/physiopathology |
Polycystic ovary syndrome Pregnancy Pregnancy Outcome Weight Loss |
Additional relevant MeSH terms:
|
Infertility Polycystic Ovary Syndrome Infertility, Female Genital Diseases, Male Genital Diseases, Female Ovarian Cysts |
Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 30, 2016