Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-20

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Female Infertility Polycystic Ovary Syndrome Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Lifestyle counseling

Group Type EXPERIMENTAL

Interdisciplinary lifestyle intervention

Intervention Type BEHAVIORAL

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.

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Lifestyle program for obese infertile women

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No