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Female InfertilityOFNCT01483612

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

A study testing Interdisciplinary lifestyle intervention in people with Female Infertility and Polycystic Ovary Syndrome, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Interdisciplinary lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteCanada
Study dates
20 Jan 2012to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

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

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.

Read more

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.

Being tested
Interdisciplinary lifestyle intervention
Keywords
Body Weight, Female, Infertility, Female/therapy, Infertility, Female/physiopathology, Obesity/physiopathology, Polycystic ovary syndrome, Pregnancy, Pregnancy Outcome, Weight Loss
Medical subject headings
Infertility, Female, Polycystic Ovary Syndrome, Obesity, Body Weight, Infertility, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interdisciplinary lifestyle interventionBehavioural

    Also called Lifestyle program for obese infertile women

    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.

Study groups in NCT01483612
Study groupRoleWhat they receive
Lifestyle counselingExperimentalNot described
Receives: Behavioral: Interdisciplinary lifestyle intervention
controlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates of live birth

    Measured: 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 (7)

  1. Fertility outcomes

    Measured: 18 months

  2. Pregnancy outcomes

    Measured: Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study

  3. Neonatal outcomes

    Measured: Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study

  4. Clinical outcomes

    Evolution of anthropometric measures, change in lifestyle habits, physical fitness level and evolution of readiness for change.

    Measured: 18 months

  5. Cost per life birth, and other measures of cost-effectiveness

    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).

    Measured: 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

  6. Clinical outcomes in male partners

    Evolution of anthropometric measures and change in lifestyle habits in male partners.

    Measured: 18 months

  7. Clinical outcomes of female participants

    Evolution of anthropometric measures, changes in lifestyle habits (diet, exercise, alcohol, tobacco), physical fitness level, evolution of readiness for change, etc.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2011 (estimated)
  2. Study start20 Jan 2012
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01483612
Sponsor's protocol ID
CIHR/FRN-114125
Acronym
OF
Status last verified
Feb 2023
First submitted
25 Nov 2011
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No

Publications

  • St-Laurent A, Belan M, Jean-Denis F, Langlois MF, Pesant MH, Carranza-Mamane B, Duval K, Morisset AS, Baillargeon JP. An interdisciplinary intervention improves lifestyle behaviours in women living with obesity and subfertility: A secondary analysis of a randomized controlled trial. Clin Nutr ESPEN. 2025 Aug;68:457-464. doi: 10.1016/j.clnesp.2025.05.036. Epub 2025 May 28.

    PubMed 40447224

  • 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.

    PubMed 26635965

Questions about this trial

What is this clinical trial studying?

A study testing Interdisciplinary lifestyle intervention in people with Female Infertility and Polycystic Ovary Syndrome, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01483612, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.

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