Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01483612
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2011-11-25
Brief Title:
Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OF
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 kgm² or overweight women with PCOS BMI 27 kgm² 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
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 kgm² or overweight women with PCOS BMI 27 kgm² 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None