Active not recruitingNAINTERVENTIONAL

Fit-for-Fertility Multicenter Randomized Controlled Trial

This study, called Fit-for-Fertility, wants to see if a healthy lifestyle program can help women with both obesity and difficulty getting pregnant. Around 1 in 10 couples struggle to get pregnant, and obesity is a common factor. This research aims to find out if the Fit-for-Fertility program, which includes meetings with dietitians and exercise experts, as well as group sessions, can improve a woman's chances of getting pregnant and having a healthy baby compared to just receiving standard fertility treatments. It will also look at whether this program can save money for individuals and the healthcare system. The study will involve around 400 women across several fertility clinics who will be randomly assigned to either the lifestyle program or standard care.

At a glance

Status

Active not recruiting

Phase

Sponsor

Université de Sherbrooke

Enrolment target

408

Start

03 Apr 2019

Estimated completion

01 Dec 2029

Obesity Infertility, Female

What is this study about?

Many couples experience difficulty getting pregnant, which is often called infertility. For women, being overweight or having obesity can sometimes make it harder to conceive. Experts believe that adopting a healthier lifestyle before trying to get pregnant and continuing it during pregnancy can be very helpful.

This study is testing a special program called Fit-for-Fertility. This program is designed to help women who are overweight or have obesity and are trying to get pregnant, by supporting them to make lasting, healthy changes to their lifestyle. The researchers want to see if this program, when combined with regular fertility treatments, is more effective than just having fertility treatments on their own. They hope that this program will not only help women get pregnant but also lead to healthier pregnancies and babies.

The study will also explore if this approach is a sensible and affordable way to help more women achieve their dream of becoming mothers. They believe that if women can make healthy changes before getting pregnant, it could also help reduce the risk of their children developing obesity or other health problems later in life, breaking a cycle that can last generations.

Key takeaways

Targets women with obesity and infertility.
Compares a lifestyle program to standard fertility care.
Aims to improve pregnancy chances and baby health.
Includes support from dietitians and exercise experts.
Participation lasts up to 24 months.
Could help reduce future health problems for children.

Who may be eligible?

This study is looking for women aged between 18 and 40 years old who are experiencing difficulty getting pregnant. This might mean you've been trying for a baby for 12 months without success, or 6 months if you have irregular periods or are over 35, or if your doctor has already identified a reason for your infertility.

You would also need to have a Body Mass Index (BMI) that indicates obesity (a BMI of 30 or more), or a BMI of 27 or more if you are of Asian or Latin American background, or if you have Polycystic Ovary Syndrome (PCOS).

There are also some reasons why you wouldn't be able to join. For example, if you have certain serious medical or mental health conditions, if your doctor says you only have one type of fertility treatment that will work (like IVF for blocked tubes), or if you've recently had multiple miscarriages. You also can't have had weight-loss surgery or be involved in another intensive lifestyle program similar to this one. You also need to be able to speak the language of the group sessions (French or English depending on the clinic) and commit to attending appointments for the next 18 months.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 18 and 40 years old?
Have you been trying to get pregnant for 12 months (or 6 months if over 35 or with irregular periods) without success, or do you have a known cause of infertility?
Do you have a Body Mass Index (BMI) of 30 or higher (or 27+ if Asian/Latin American or with PCOS)?
Are you able to speak English or French and attend appointments for about 18 months?
Have you not had weight-loss surgery and are not involved in another intensive lifestyle program?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have an initial assessment. After this, you'll be randomly assigned to one of two groups, like flipping a coin. One group will participate in the Fit-for-Fertility program for six months, followed by their usual fertility treatments. The other group will start their standard fertility treatments straight away.

If you're in the Fit-for-Fertility group, you'll have one-on-one meetings with a dietitian and an exercise specialist every 6 to 12 weeks. These individual sessions will continue for up to 18 months or until you become pregnant. You'll also attend eight group education sessions. Regardless of which group you're in, you'll have check-up visits every six months for 18 months. If you become pregnant, you'll also have assessments early in your pregnancy and again at 26 weeks of pregnancy. The study will then follow up on your progress for a total of 24 months to see the overall results.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving specialised support to improve your health and potentially your chances of getting pregnant and having a healthy baby, which you might not otherwise access. Joining a study also contributes to scientific knowledge that can help many others in the future. As with any medical study, there might be some time commitment involved with appointments, and while the lifestyle changes are aimed at improving health, some people might find them challenging. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Olive Fertility Centre
Verified postcode
Vancouver, Canada
Mount Sinai Hospital
Verified postcode
Toronto, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Verified postcode
Montreal, Canada
Centre hospitalier de l'Université Laval
Verified postcode
Québec, Canada
Centre hospitalier universitaire de Sherbrooke
Verified postcode
Sherbrooke, Canada

Common questions

What is 'infertility' in this study?

Infertility refers to not getting pregnant after 12 months of regular unprotected sex, or 6 months if you have irregular periods or are over 35, or if your doctor has already found a reason.

What does a 'lifestyle intervention' mean?

It means a program designed to help you make healthy changes to your diet and physical activity habits, with support from experts.

Will I still receive my regular fertility treatments?

Yes, depending on which group you're in, you will either start with the lifestyle program then receive treatments, or receive standard treatments throughout.

How long will I be involved in the study?

You will have regular appointments and follow-ups for up to 18 months, with overall tracking for 24 months.

Why is Body Mass Index (BMI) mentioned?

BMI is a measure used to check if your weight is healthy for your height. This study is specifically for women with a BMI indicating overweight or obesity.