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Fit-for-Fertility Program for Female Infertility and Obesity (FFF Trial)

N/A
Recruiting
Led By Jean-Patrice Baillargeon, MD, MSc
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged between 18 and 40 years
Aged between 18 and 40 years;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

FFF Trial Summary

This trial will assess the effectiveness of a lifestyle intervention program (Fit-For-Fertility) for women with obesity who are struggling with infertility. The hypothesis is that the program will be an efficient and low cost solution to help these women become pregnant and have a healthy baby.

Who is the study for?
Women aged 18-40 with obesity and infertility, defined as not achieving pregnancy after regular unprotected sex for at least a year, or six months if over 35 or with irregular cycles. Excludes those with uncontrolled eating disorders, major depression, recurrent miscarriages without conception issues, planning bariatric surgery or other lifestyle interventions, language barriers to session participation, certain fertility treatment ineligibilities, plans to move away within 18 months, or any condition that contra-indicates fertility treatments.Check my eligibility
What is being tested?
The trial is testing the Fit-for-Fertility program against standard fertility care. The program includes individual sessions with dietitians and kinesiologists every 6-12 weeks plus eight educational group sessions aimed at sustainable lifestyle changes. Participants will be randomly assigned to either this intervention group or a control group receiving usual treatments.See study design
What are the potential side effects?
Since the intervention involves lifestyle changes through diet and exercise guidance rather than medication there are no typical 'side effects' like you'd expect from drugs; however participants may experience discomfort adjusting to new routines.

FFF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.
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I am between 18 and 40 years old.
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I am overweight according to my BMI, especially considering my PCOS condition.
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I am overweight according to my BMI, fitting the criteria for my condition.

FFF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Live birth rate
Secondary outcome measures
Anthropometric measures - BMI
Anthropometric measures - Fat percentage
Blood markers - Endocrine panel
+32 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

FFF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fit-For-Fertility programExperimental Treatment1 Intervention
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).
Group II: Standard of careActive Control1 Intervention
The control intervention will consist of immediate initiation of usual fertility care, as recommended by each fertility specialist, for a maximum of 24 months.

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
288 Previous Clinical Trials
68,292 Total Patients Enrolled
1 Trials studying Female Infertility
130 Patients Enrolled for Female Infertility
Centre de recherche du Centre hospitalier universitaire de SherbrookeOTHER
57 Previous Clinical Trials
30,537 Total Patients Enrolled
Ferring PharmaceuticalsIndustry Sponsor
310 Previous Clinical Trials
439,994 Total Patients Enrolled
3 Trials studying Female Infertility
1,452 Patients Enrolled for Female Infertility

Media Library

Fit-For-Fertility program Clinical Trial Eligibility Overview. Trial Name: NCT03908099 — N/A
Female Infertility Research Study Groups: Fit-For-Fertility program, Standard of care
Female Infertility Clinical Trial 2023: Fit-For-Fertility program Highlights & Side Effects. Trial Name: NCT03908099 — N/A
Fit-For-Fertility program 2023 Treatment Timeline for Medical Study. Trial Name: NCT03908099 — N/A
Female Infertility Patient Testimony for trial: Trial Name: NCT03908099 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the prerequisites for enrollment in this experiment?

"This medical trial is currently enrolling 616 volunteers aged between 18 and 40 years old who meet the criteria of obesity (BMI ≥ 30 kg/m² or 27 kg/m² for Asian and Latin American), or overweight in cases of PCOS (BMI ≥ 27 kg/m²). Additionally, all applicants must have experienced a year-long lack of conception despite regular unprotected intercourse, or display another accepted cause of infertility."

Answered by AI

What is the current enrolment in this clinical experiment?

"The trial sponsor, Ferring Pharmaceuticals, needs a total of 616 qualifying participants to launch the study. This will be done from multiple sites including Centre hospitalier universitaire de Sherbrooke in Quebec and Olive Fertility Clinic in British Columbia."

Answered by AI

Are there plentiful sites carrying out this clinical trial in the United States?

"Currently, 6 different clinical trial sites are enrolling participants. These locations include Sherbrooke, Vancouver, Montréal and other cities nearby. To minimize your travel requirements if you decide to take part in the study, it is wise to opt for a centre closest to home."

Answered by AI

Is it possible for individuals over the age of fifty to join this trial?

"The age restrictions for this medical trial are 18 to 40 years old."

Answered by AI

Is the research project still open to participants?

"Affirmative. On clinicaltrials.gov, the information confirms that this investigation is actively recruiting individuals. It was initially posted on April 3rd 2019 and was most recently updated at June 26th 2022; 616 subjects from six medical centres need to be recruited for the trial."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Olive Fertility Centre
Other
Centre hospitalier de l'Université de Montréal (CHUM)
Mount Sinai Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

You caught my eye!
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is this a safe and paid trial and I would also like to know if you work with Americans and would I need to consistently travel there?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
~186 spots leftby Apr 2026