Clinical trial · Interventional
Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women
"Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Female Infertility | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interdisciplinary lifestyle intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lifestyle counseling
- interventionNames
- Behavioral: Interdisciplinary lifestyle intervention
- type
- NO_INTERVENTION
- label
- control
Primary outcomes (1)
- 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 (7)
- measure
- Fertility outcomes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSt-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. PMID 40447224
- DERIVEDDuval 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. PMID 26635965