Fit-for-Fertility Program for Female Infertility and Obesity

(FFF Trial)

Recruiting at 4 trial locations

Overseen By Farrah Jean-Denis, MSc

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Uncontrolled conditions, IVF only, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

408 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Fit-for-Fertility Program safe for women with obesity and infertility?

The Fit-for-Fertility Program, which involves lifestyle changes for women with obesity and infertility, has been studied for its effects on pregnancy outcomes. While it may slightly increase pregnancy rates, it also appears to increase the risk of miscarriage. More research is needed to fully understand its safety and effectiveness. ^{1 2 3 4 5}

How is the Fit-For-Fertility treatment different from other treatments for female infertility and obesity?

The Fit-For-Fertility program is unique because it focuses on an interdisciplinary lifestyle intervention specifically designed for women with obesity and infertility, rather than relying on medical or surgical treatments. This approach aims to improve fertility through lifestyle changes, which have been less frequently studied in robust trials compared to other methods. ^{4 5 6 7 8}

What data supports the effectiveness of the Fit-For-Fertility treatment for female infertility and obesity?

Research suggests that lifestyle changes, including diet and exercise, can improve reproductive outcomes in overweight or obese women with infertility. The Fit-For-Fertility program, which focuses on these lifestyle changes, aims to help women with obesity and infertility by promoting weight loss and healthy habits, which are known to positively impact fertility. ^{4 5 7 9 10}

Who Is on the Research Team?

Jean-Patrice Baillargeon, MD, MSc

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am overweight according to my BMI, fitting the criteria for my condition.

I am overweight according to my BMI, especially considering my PCOS condition.

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

Exclusion Criteria

I am planning to have or have had weight loss surgery.

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

You have a history of severe eating disorders or major depression that would make it unsuitable for you to participate in a lifestyle intervention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants in the intervention group follow the Fit-for-Fertility Program alone for 6 months

6 months

Individual sessions every 6-12 weeks, 8 group sessions

Combined Treatment

Participants in the intervention group continue the Fit-for-Fertility Program in combination with usual fertility treatments

12 months

Evaluation visits every 6 months

Follow-up

Participants are monitored for fertility, pregnancy, and neonatal outcomes

24 months

Research evaluation visits every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fit-For-Fertility program
• Standard of care

Trial Overview 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.

How Is the Trial Designed?

Group I: Fit-For-Fertility program Experimental Treatment 1 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 care Active Control 1 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.

Fit-For-Fertility program is already approved in Canada for the following indications:

Approved in Canada as Fit-For-Fertility Program for:

• Infertility in women with obesity

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

Ferring Pharmaceuticals

Industry Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

Published Research Related to This Trial

In a study of 56 overweight and obese infertile patients, weight loss guidance did not lead to a decrease in weight or BMI; instead, patients' average weight and BMI increased after the guidance, indicating that the intervention was ineffective.

The findings suggest that simply providing weight loss guidance is insufficient for this population, and that additional support from nutritionists or endocrinologists may be necessary to achieve meaningful weight loss and improve fertility outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of weight loss orientation on BMI in obese and overweight infertile patients. Benetti, BBDC., Approbato, MS., Approbato, FC.[2023]

The intensive weight loss intervention (IWL) led to a significant average weight loss of 13% in obese subfertile women, compared to only 4% in the standard-of-care nutrition counseling (SCN) group, indicating that IWL is more effective for weight management.

IWL resulted in improved reproductive outcomes, with three out of six women conceiving and delivering term pregnancies, while no pregnancies occurred in the SCN group, suggesting that IWL may enhance fertility in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a brief, intensive weight loss intervention to improve reproductive outcomes in obese, subfertile women: a pilot study. Rothberg, A., Lanham, M., Randolph, J., et al.[2020]

The Fit-For-Fertility Programme (FFFP) is being tested in a randomized controlled trial involving 616 women with obesity and subfertility to assess its impact on live birth rates and other fertility outcomes over 24 months.

This study aims to provide evidence on the effectiveness and cost-effectiveness of lifestyle interventions for women with obesity seeking fertility treatments, which could influence future care policies and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol of the Fit-For-Fertility study: a multicentre randomised controlled trial assessing a lifestyle programme targeting women with obesity and infertility. Belan, M., Gélinas, M., Carranza-Mamane, B., et al.[2022]

This study will evaluate the effectiveness of a 3-month online program promoting healthy lifestyle changes in 94 overweight or obese women with infertility, comparing it to standard medical care.

The primary goal is to assess the impact of this intervention on spontaneous pregnancy rates, while also measuring secondary outcomes like changes in body composition, dietary habits, and quality of life related to fertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an Internet-Based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: Study Protocol for a Randomised Controlled Trial. Biviá-Roig, G., Blasco-Sanz, R., Boldó-Roda, A., et al.[2021]

In a study of 188 poor ovarian responders (POR) undergoing IVF, obese women (BMI ≥30) had significantly lower fertilization rates compared to normal weight and overweight women, indicating that obesity negatively impacts IVF outcomes.

Obese women also experienced lower clinical pregnancy rates (15%) compared to normal weight women (33.3%), suggesting that obesity is a critical factor affecting reproductive success in IVF, despite similar oocyte maturity and gonadotropin treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Overweight and Obesity in In Vitro Fertilization Outcomes of Poor Ovarian Responders. Vural, F., Vural, B., Çakıroğlu, Y.[2018]

Lifestyle interventions for weight loss in obese infertile women showed a slight increase in pregnancy rates (relative risk of 1.43), but did not significantly improve live birth rates (relative risk of 1.39), indicating uncertainty about their effectiveness in achieving successful pregnancies.

The study also found that these lifestyle programs may increase the risk of miscarriage (relative risk of 1.50), suggesting that while weight loss can improve some aspects of fertility, it may also pose risks that need to be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Lifestyle Intervention on Pregnancy and Birth Outcomes on Obese Infertile Women: A Systematic Review and Meta-Analysis. Espinós, JJ., Solà, I., Valli, C., et al.[2023]

In a study of 72 women with polycystic ovary syndrome (PCOS) undergoing their first IVF cycle, those with a body mass index (BMI) of 40 kg/m² or higher had significantly lower clinical pregnancy rates (32%) compared to those with a BMI under 40 kg/m² (72%).

While the live birth rates were also lower in morbidly obese women (32% vs. 60%), this difference was not statistically significant, suggesting that weight loss might improve IVF outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbid obesity is associated with lower clinical pregnancy rates after in vitro fertilization in women with polycystic ovary syndrome. Jungheim, ES., Lanzendorf, SE., Odem, RR., et al.[2021]

In a study of 105 infertile women undergoing intracytoplasmic sperm injection (ICSI), the fatty acid composition of follicular fluid did not significantly differ across body mass index (BMI) groups, except for a marginal difference in stearic acid.

The study found that higher BMI was inversely associated with the percentage of mature oocytes and that certain fatty acids in follicular fluid may influence pregnancy outcomes, suggesting the importance of nutritional counseling for patients before assisted reproductive techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does different BMI influence oocyte and embryo quality by inducing fatty acid in follicular fluid? Mirabi, P., Chaichi, MJ., Esmaeilzadeh, S., et al.[2017]

This report offers updated guidelines for clinicians on how to evaluate and treat infertility in couples affected by obesity, reflecting the latest research and practices since the last publication in 2015.

The document emphasizes the importance of addressing obesity as a significant factor in infertility, suggesting that weight management may improve reproductive outcomes for affected couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and reproduction: a committee opinion. [2021]

Obesity negatively impacts fertility in women, potentially due to hormonal changes such as high levels of leptin, insulin, and androgens, although the exact mechanisms are not fully understood.

There is promising evidence for various interventions, including pharmacotherapy, bariatric surgery, and assisted reproduction, aimed at improving fertility rates in obese women, but more research is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical and surgical interventions to improve outcomes in obese women planning for pregnancy. Sharma, A., Bahadursingh, S., Ramsewak, S., et al.[2016]

Citations

1. Brazil pubmed.ncbi.nlm.nih.gov

Effect of weight loss orientation on BMI in obese and overweight infertile patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a brief, intensive weight loss intervention to improve reproductive outcomes in obese, subfertile women: a pilot study. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Protocol of the Fit-For-Fertility study: a multicentre randomised controlled trial assessing a lifestyle programme targeting women with obesity and infertility. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of an Internet-Based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: Study Protocol for a Randomised Controlled Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The Role of Overweight and Obesity in In Vitro Fertilization Outcomes of Poor Ovarian Responders. [2018]

6. Iran pubmed.ncbi.nlm.nih.gov

The Effect of Lifestyle Intervention on Pregnancy and Birth Outcomes on Obese Infertile Women: A Systematic Review and Meta-Analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Morbid obesity is associated with lower clinical pregnancy rates after in vitro fertilization in women with polycystic ovary syndrome. [2021]

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Does different BMI influence oocyte and embryo quality by inducing fatty acid in follicular fluid? [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Obesity and reproduction: a committee opinion. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Medical and surgical interventions to improve outcomes in obese women planning for pregnancy. [2016]