Clinical trial NCT01483612: Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women
Official title: "Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Infertility
Polycystic Ovary Syndrome
Obesity
Keywords: Body Weight
Female
Infertility, Female/therapy
Infertility, Female/physiopathology
Obesity/physiopathology
Polycystic ovary syndrome
Pregnancy
Pregnancy Outcome
Weight Loss
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ministere de la Sante et des Services Sociaux
First posted: 2011-12-01
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rates of live birth
timeFrame: 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
timeFrame: 18 months
measure: Pregnancy outcomes
timeFrame: Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study
measure: Neonatal outcomes
timeFrame: Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study
measure: Clinical outcomes
timeFrame: 18 months
measure: Cost per life birth, and other measures of cost-effectiveness
timeFrame: 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
measure: Clinical outcomes in male partners
timeFrame: 18 months
measure: Clinical outcomes of female participants
timeFrame: 18 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Patrice Baillargeon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duval K, Langlois MF, Carranza-Mamane B, Pesant MH, Hivert MF, Poder TG, Lavoie HB, Ainmelk Y, St-Cyr Tribble D, Laredo S, Greenblatt E, Sagle M, Waddell G, Belisle S, Riverin D, Jean-Denis F, Belan M, Baillargeon JP. The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. BMC Obes. 2015 Dec 1;2:47. doi: 10.1186/s40608-015-0077-x. eCollection 2015.