NCT03908099Active, not recruiting

Fit-for-Fertility Multicenter Randomized Controlled Trial

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

Source: ClinicalTrials.gov · Last updated 19 Mar 2025

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 408 (estimated)
First submitted: 2 Apr 2019
Start date: 3 Apr 2019
Primary completion date: Dec 2029
Lead sponsor: Université de Sherbrooke
Diseases: Obesity
NCT number: NCT03908099

What you commit to

Study type: Interventional
Planned participants: 408
From 3 Apr 2019 to the primary completion date, Dec 2029
5 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previously diagnosed uncontrolled eating disorder or major depression that would contra-indicate the initiation of a lifestyle intervention;

Other illness

Any uncontrolled medical or mental condition that contra-indicates fertility treatments, based on clinical judgment of the fertility specialist;
Planning for or past history of bariatric surgery;

Other

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;
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.
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;
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);
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
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.

Who the study is looking for

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;
Aged between 18 and 40 years; and
Obesity (BMI ≥ 30 kg/m² or 27 kg/m² for Asian and Latin American), or overweight for women with PCOS (BMI ≥ 27 kg/m²).

Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status	Montreal	Canada	Unknown status
Centre hospitalier de l'Université Laval Coordinator of this site? Confirm its status	Québec	Canada	Unknown status
Centre Hospitalier Universitaire de Sherbrooke Coordinator of this site? Confirm its status	Sherbrooke	Canada	Unknown status
Mount Sinai Hospital Coordinator of this site? Confirm its status	Toronto	Canada	Unknown status
Olive Fertility Centre Coordinator of this site? Confirm its status	Vancouver	Canada	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.