Clinical Trial

Fit-for-Fertility Multicenter Randomized Controlled Trial

Study Description

Fit-for-Fertility Multicenter Randomized Controlled Trial

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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 weekl ...read more on ClinicalTrials.org

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 month ...read more on ClinicalTrials.org

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03908099

ParticipAid ID

erkNLa