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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;
Must not have
Planning for or past history of bariatric surgery
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the Fit-For-Fertility program, which helps women with obesity and infertility adopt healthier lifestyles. The program includes sessions with dietitians and kinesiologists, and group education. It aims to improve fertility and reduce treatment costs by promoting sustainable healthy habits.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
Select...
I am between 18 and 40 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am planning to have or have had weight loss surgery.
Select...
My depression score is not high, making me eligible for a lifestyle change program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Live birth rate
Secondary study objectives
Anthropometric measures - BMI
Anthropometric measures - Fat percentage
Blood markers - Endocrine panel
+32 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for female infertility include lifestyle changes, ovulation induction, and surgical interventions. Lifestyle changes, such as those promoted in the Fit-For-Fertility Program, focus on weight management through diet and exercise, which can improve hormonal balance and ovulatory function.
Ovulation induction uses medications like clomiphene citrate or gonadotropins to stimulate the ovaries to produce eggs, addressing issues of anovulation. Surgical interventions, such as the resection or ablation of endometriosis, can improve fertility by removing tissue that interferes with reproductive function.
These treatments are crucial as they address underlying issues that impair fertility, thereby increasing the chances of conception and successful pregnancy.
Poor responders in assisted reproduction cycles.Gonadotropin releasing hormone agonist protocols for pituitary desensitization in in vitro fertilization and gamete intrafallopian transfer cycles.
Poor responders in assisted reproduction cycles.Gonadotropin releasing hormone agonist protocols for pituitary desensitization in in vitro fertilization and gamete intrafallopian transfer cycles.
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Who is running the clinical trial?
Université de SherbrookeLead Sponsor
305 Previous Clinical Trials
76,313 Total Patients Enrolled
1 Trials studying Female Infertility
130 Patients Enrolled for Female Infertility
Centre de recherche du Centre hospitalier universitaire de SherbrookeOTHER
61 Previous Clinical Trials
32,898 Total Patients Enrolled
Ferring PharmaceuticalsIndustry Sponsor
322 Previous Clinical Trials
1,241,635 Total Patients Enrolled
3 Trials studying Female Infertility
1,472 Patients Enrolled for Female Infertility
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Fit-For-Fertility program
- Group 2: Standard of care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Female Infertility Patient Testimony for trial: Trial Name: NCT03908099 — N/A
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