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ACTIVE NOT RECRUITING

NCT03908099

Fit-for-Fertility Multicenter Randomized Controlled Trial

Sponsor: Université de Sherbrooke

View on ClinicalTrials.gov

Summary

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 408 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.

Official title: Fit-for-Fertility Multicenter Randomized Controlled Trial: Improving Reproductive, Maternal and Neonatal Outcomes in Obese and Infertile

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

408

Start Date

2019-04-03

Completion Date

2029-12

Last Updated

2025-03-19

Healthy Volunteers

Conditions

Obesity Infertility, Female

Interventions

BEHAVIORAL

Fit-For-Fertility program

The Fit-for-Fertility Program aims at implementing progressive and sustainable lifestyle changes. Participants will attend individual sessions with a dietitian and a kinesiologist every 6 weeks for the first 6 months, then every 8 weeks for the 6 following months, and then every 12 weeks until end of the study. Follow-up by telephone/e-mail will be offered between in-person meetings. These professionals will be trained in motivational counselling skills. Participants will also benefit from weekly group sessions divided into 2 parts: 1) Workshops covering 8 different topics (45 minutes) addressing healthy lifestyle and 2) Supervised classes of physical activity where one of 8 different types of exercise (45 minutes) will be practiced. Women will be required to attend all 8 different sessions within the first 6 months. Pregnant women will be met to set new lifestyle objectives specific to pregnancy, including optimal gestational weight gain based on the Institute of Medicine guidelines.

OTHER

Standard of care

The control intervention will consist of immediate initiation of usual fertility care, as recommended by each fertility specialist, for a maximum of 24 months. The experimental intervention will be the Fit-for-Fertility Program alone for the first 6 months, then in combination with usual fertility care for an additional 12 months and thereafter, usual fertility care can continue to be provided alone for a maximum follow-up of 24 months. The lifestyle program is provided for a maximum of 18 months if there is no pregnancy, or otherwise, up to the end of pregnancy or to a total study follow-up of 24 months (whichever comes first).

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 β-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.

Locations (5)

Olive Fertility Centre

Vancouver, British Columbia, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Centre hospitalier de l'Université Laval

Québec, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada