Obesity Clinical Trial
— FFFOfficial title:
Fit-for-Fertility Multicenter Randomized Controlled Trial: Improving Reproductive, Maternal and Neonatal Outcomes in Obese and Infertile
Infertility affects approximately 10-15% of couples and one of its important modifiable risk factor is obesity, which affects 19% of Canadian women of reproductive age. Accordingly, many organizations have recommended that women should be assisted to adopt a healthy lifestyle prior to conception and maintain it during pregnancy. We therefore propose to conduct a multicenter randomized controlled trial (RCT) assessing the lifestyle intervention Fit-For-Fertility in women with infertility and obesity. Our hypothesis is that the Fit-For-Fertility program is an efficient and low cost solution to improve access to motherhood for women suffering from obesity and infertility. To test our hypothesis, seven fertility clinics having a good ethnic diversity will participate in this RCT and recruit a total of 616 women with obesity (BMI according to ethnicity) who consult at the fertility clinic. Participants will be randomly allocated to one of these two groups: the intervention group will be invited to participate in the Fit-for Fertility Program alone for 6 months and then in combination with usual fertility treatments; while the control group will receive standard fertility treatments from randomisation. The aim of the Fit-for Fertility Program will be to implement progressive and sustainable lifestyle changes, using 1) individual sessions with a dietitian and a kinesiologist every 6-12 weeks, for a total of 18 months or until the end of pregnancy; and 2) eight educational group sessions. Evaluation visits will take place prior to randomisation and then every 6 months for 18 months. Women who become pregnant will be evaluated early during pregnancy and at 26 weeks of gestation. Clinical outcomes will be assessed after a total follow up of 24 months. Anticipated contributions: The results of our multicenter RCT will provide important data on the importance of a lifestyle program supporting women with obesity consulting in fertility clinics, in order to improve their fertility and response to ART, as well as helping them to have a healthy baby. This study will also provide valuable information on potential cost savings for individuals and the healthcare system.
Status | Recruiting |
Enrollment | 616 |
Est. completion date | October 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Infertility defined as (a) failure to achieve a clinical pregnancy after =12 months of regular unprotected sexual intercourse, (b) not conceiving after having tried =6 months in women with irregular menstrual cycles or =35 years of age; or (c) women with an established cause of infertility; 2. Aged between 18 and 40 years; and 3. Obesity (BMI = 30 kg/m² or 27 kg/m² for Asian and Latin American), or overweight for women with PCOS (BMI = 27 kg/m²). Exclusion Criteria: 1. Any uncontrolled medical or mental condition that contra-indicates fertility treatments, based on clinical judgment of the fertility specialist; 2. If the only clinically indicated MAR procedure is IVF (e.g. bilateral tubal factor, severe male factor, etc.) or in case of insemination with donor, because natural conception is impossible or highly unlikely; 3. Recurrent spontaneous abortions (>2 miscarriages at less than 22 weeks of gestation) within the last 12 months (with evidence of conception, such as positive ß-hCG), because these women do not have difficulty to conceive. 4. Previously diagnosed uncontrolled eating disorder or major depression that would contra-indicate the initiation of a lifestyle intervention; 5. A high level of depressive state, as determined by a score for depression on the Hospital Anxiety and Depression Scale (HADS) = 15, since that would contra-indicate the initiation of a lifestyle intervention; 6. Planning for or past history of bariatric surgery; 7. Planning for or engaging in another intensive lifestyle intervention (that includes face-to-face visits every 8 weeks or less, which would be similar to the intervention tested); 8. Inability to understand the language in which group sessions will be provided in the participating center, i.e. French in Quebec province and English in other provinces; and 9. Planning to be unable to attend research visits at the participating center for the next 18 months, due to moving in another region, for example. |
Country | Name | City | State |
---|---|---|---|
Canada | Pacific Centre for Reproductive Medicine | Edmonton | Alberta |
Canada | IWK Health Centre | Halifax | New Brunzwick |
Canada | Centre hospitalier de l'Université de Montréal (CHUM) | Montréal | Quebec |
Canada | Centre hospitalier de l'Université Laval | Québec | Quebec |
Canada | Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Olive Fertility Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Ferring Pharmaceuticals |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live birth rate | Cumulative incidence of live birth, based on medical record/questionnaire. | 24 months | |
Secondary | Fertility Outcomes - Rate of biochemical pregnancy | Confirmed by a positive serum ß-hCG), based on medical record. | 24 months | |
Secondary | Fertility Outcomes - Rate of ongoing pregnancy | Viable pregnancy of =10 weeks of gestation, based on medical record. | 24 months | |
Secondary | Fertility Outcomes - Rate of spontaneous miscarriage | <22 gestational weeks, based on medical record/questionnaire. | 24 months | |
Secondary | Fertility Outcomes - Rate of multiple gestation | More than one fetal heart beat, based on medical record. | 24 months | |
Secondary | Fertility Outcomes - Rate of spontaneous pregnancy | Without following MAR procedures, based on medical record/questionnaire. | 24 months | |
Secondary | Fertility Outcomes - Rate of pregnancy following MAR procedures | By procedures, based on medical record. | 24 months | |
Secondary | Fertility Outcomes - Doses of fertility medications per participant | required during MAR cycles, based on medical record. | 24 months | |
Secondary | Fertility Outcomes - Number of MAR and/or ART cycles per participant | Number of MAR and/or ART cycles, based on medical record. | 24 months | |
Secondary | Fertility Outcomes - Frequency of embryo transfers | After IVF procedures, based on medical record. | 24 months | |
Secondary | Fertility Outcomes - Frequency of complications due to MAR procedures | All type of complications directly related to MAR, based on medical record. | 24 months | |
Secondary | Lifestyle outcomes - Nutrient intake | Using a web-based, food frequency questionnaire. | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Physical activity behaviours | Using the International Physical Activity Questionnaires (IPAQ). | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Measures of physical activity | Daily energy expenditure, time spent in various physical activity intensities and step count, using a blinded Fitbit Flex 2 wristband for 7 consecutive days following the visit. | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Physical fitness level | Using the six-minute walk test. | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Other lifestyles | such as alcohol, tobacco and drugs, using a questionnaire. | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Sleep duration and quality | Using the Pittsburgh Sleep Quality Index. | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Sleep stages | Using the Fitbit Flex 2 wristband. | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Perceived competence | Using the Perceived Competence Scale. | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Readiness | Using a conviction/confidence and readiness questionnaire | 18 months or end of pregnancy | |
Secondary | Lifestyle outcomes - Anxiety/depression | Using the Hospital Anxiety and Depression Scale (HADS). | 18 months or end of pregnancy | |
Secondary | Anthropometric measures - BMI | weight and height will be combined to report BMI in kg/m^2; measures will be performed using a standard calibrated scale and stadiometer. | 18 months or end of pregnancy | |
Secondary | Anthropometric measures - Fat percentage | Using a foot-to-foot bioimpedance scale, in sites having this equipment. | 18 months or end of pregnancy | |
Secondary | Blood markers - Sex steroids | Fasting levels. | 18 months or end of pregnancy | |
Secondary | Blood markers - Endocrine panel | Fasting levels. | 18 months or end of pregnancy | |
Secondary | Blood markers - Metabolic panel | Fasting levels. | 18 months or end of pregnancy | |
Secondary | Incremental health-related cost-effectiveness ratio of live birth | Using costs questionnaires and other sources of data that will be aggregated at this reported value. | 24 months | |
Secondary | Pregnancy outcomes - Gestational weight gain | estimated by subtracting weight at the research visit closest to the onset of pregnancy from both the weight at the last research visit and the last weight available in the record. | 24 months | |
Secondary | Pregnancy outcomes - Gestational complications | such as gestational diabetes, gestational hypertensive disorders, thromboembolism, preterm birth, late fetal loss, stillbirth and post-partum hospital stay >7 days. | 24 months | |
Secondary | Neonatal outcomes - Birth weight | Based on medical record. | 24 months | |
Secondary | Neonatal outcomes - Apgar score | Based on medical record. | 24 months | |
Secondary | Neonatal outcomes - Hypoglycemia | Based on medical record. | 24 months | |
Secondary | Neonatal outcomes - Jaundice | Based on medical record. | 24 months | |
Secondary | Neonatal outcomes - Birth trauma | Based on medical record. | 24 months | |
Secondary | Neonatal outcomes - Admission to neonatal intensive care unit | Based on medical record. | 24 months | |
Secondary | Neonatal outcomes - Death | Neonatal death up to 28 days of life, based on medical record. | 24 months |
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