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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Université de Sherbrooke
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Jean-Patrice Baillargeon, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01483612
First received: November 25, 2011
Last updated: April 10, 2014
Last verified: April 2014
  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"

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483612

Contacts
Contact: Jean-Patrice Baillargeon, Dr. 819-346-1110 ext 14853 Jean-Patrice.Baillargeon@usherbrooke.ca

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Farrah Jean-Denis, Dt.P, M.Sc.    819-346-1110 ext 12814    fjeandenis.chus@ssss.gouv.qc.ca   
Principal Investigator: Jean-Patrice Baillargeon, MD         
Sub-Investigator: Belina Carranza-Mamane, MD         
Sub-Investigator: Marie-Hélène Pesant, MD         
Sub-Investigator: Marie-France Hivert, MD         
Sub-Investigator: Marie-France Langlois, MD         
Sub-Investigator: Thomas Poder, PhD         
Sponsors and Collaborators
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Investigators
Principal Investigator: Jean-Patrice Baillargeon, MD Université de Sherbrooke
  More Information

No publications provided

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: April 10, 2014
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
Infertility, Female
Genital Diseases, Female
Obesity
Polycystic Ovary Syndrome
Genital Diseases, Male
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014