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临床试验/NCT01483612
NCT01483612已完成不适用

"Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2012年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Rates of live birth

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Rates of live birth

时间窗: 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

次要结局

  • Fertility outcomes(18 months)
  • 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)
  • 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)
  • 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)
  • Clinical outcomes in male partners(18 months)
  • Clinical outcomes of female participants(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Patrice Baillargeon

Associate Professor

Université de Sherbrooke

研究点 (2)

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