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Fit-for-Fertility Program for Female Infertility and Obesity (FFF Trial)
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.
FFF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFFF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FFF Trial Design
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Who is running the clinical trial?
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- I am planning to have or have had weight loss surgery.You have a history of severe eating disorders or major depression that would make it unsuitable for you to participate in a lifestyle intervention.I am overweight according to my BMI, fitting the criteria for my condition.I am not planning to join another intensive lifestyle program soon.I am overweight according to my BMI, especially considering my PCOS condition.I am between 18 and 40 years old.I need IVF or donor insemination as natural conception is not possible for me.You have been trying to get pregnant without success for a year or longer, or you are over 35 years old and have been trying for six months or longer. If you have a medical reason that makes it difficult to get pregnant, you will also be excluded.My depression score is not high, making me eligible for a lifestyle change program.I am between 18 and 40 years old.
- Group 1: Fit-For-Fertility program
- Group 2: Standard of care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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