Fit-for-Fertility Program for Female Infertility and Obesity

(FFF Trial)

Not currently recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a lifestyle program called Fit-For-Fertility can improve pregnancy chances for women dealing with both infertility and obesity. The program emphasizes sustainable lifestyle changes with guidance from dietitians and exercise specialists, aiming to support healthier pregnancies. Women who have struggled to conceive naturally for over a year and have obesity, especially those with conditions like PCOS (polycystic ovary syndrome), may be suitable candidates for this trial. Participants will either join the program and later combine it with standard fertility treatments or begin with standard treatments immediately. The study aims to demonstrate how these lifestyle changes could enhance the effectiveness of fertility treatments and improve overall health. As an unphased trial, this study offers a unique opportunity to explore innovative lifestyle interventions that could enhance fertility treatment outcomes.

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.

What prior data suggests that the Fit-For-Fertility program is safe for women with infertility and obesity?

Research shows that the Fit-For-Fertility program helps women with obesity and infertility by encouraging healthy lifestyle changes. The program includes meetings with health experts and group learning sessions. In a previous study, women participated in this program for six months before starting their usual fertility treatments.

The available data shows no major safety concerns with the Fit-For-Fertility program. Since it focuses on healthy lifestyle changes, most people find it easy to follow. Studies have reported no harmful side effects, suggesting that the program is safe for participants and emphasizes gradual and lasting lifestyle improvements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fit-for-Fertility program because it offers a holistic approach to treating female infertility linked to obesity. Unlike standard fertility treatments that typically focus on medical interventions, this program emphasizes lifestyle changes, which include tailored diet and exercise plans. By integrating these customized lifestyle modifications with usual fertility care, the program aims to enhance overall fertility health and potentially improve pregnancy outcomes. This dual approach is what sets it apart from traditional methods and has the potential to offer a more comprehensive solution for women struggling with these interconnected challenges.

What evidence suggests that the Fit-For-Fertility program could be an effective treatment for female infertility and obesity?

Research shows that lifestyle changes can greatly improve fertility for women with obesity. In this trial, participants in the Fit-For-Fertility program will focus on healthy eating and regular exercise, which aid in weight control and overall well-being. Other studies have found that women who adopt healthy habits, similar to those in the Fit-For-Fertility program, have higher chances of getting pregnant. Specifically, women in similar programs have experienced more live births over 18 months. This approach is believed to boost fertility by supporting the body's natural functions. While specific data on the Fit-For-Fertility program is still being collected, related research strongly supports lifestyle changes as a helpful way to address infertility linked to obesity. ^{2 5 6 7 8}

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 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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35440463/

Protocol of the Fit-For-Fertility study: a multicentre ... Women from both groups are evaluated every 6 months for a maximum of 18 months. The primary outcome is live birth rate at 24 months. Secondary ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/12/4/e061554

Protocol of the Fit-For-Fertility study The primary outcome is live birth rate at 24 months. Secondary outcomes include fertility, pregnancy and neonatal outcomes; lifestyle and anthropometric ...

3. withpower.com withpower.com/trial/phase-infertility-female-3-2019-70e62

Fit-for-Fertility Program for Female Infertility and Obesity ... 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 ...

4. clinicaltrial.be clinicaltrial.be/fr/details/64305?per_page=100&only_recruiting=1&only_eligible=0&only_active=0

Fit-for-Fertility Multicenter Randomized Controlled Trial... The analysis of the 108 women who completed at least 6 months in the study (83%) shows that after a maximum follow-up of 18 months and in ...

5. academic.oup.com academic.oup.com/jes/article/5/Supplement_1/A730/6241569

Cost-Effectiveness Analysis of an Interdisciplinary Lifestyle ... The purpose of this study was to conduct a cost-effectiveness analysis (CEA) of an interdisciplinary lifestyle intervention (Fit-for-Fertility ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9020282/

Protocol of the Fit-For-Fertility study: a multicentre randomised ... This study compared 287 women with obesity and subfertility who were randomised to a 6-month structured lifestyle intervention (including six ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/12/4/e061554.abstract

Protocol of the Fit-For-Fertility study: a multicentre ... The primary outcome is live birth rate at 24 months. Secondary outcomes include fertility, pregnancy and neonatal outcomes; lifestyle and anthropometric ...

8. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003883

The FIT-PLESE randomized controlled trial | PLOS Medicine There were no significant differences in the incidence of healthy live births [standard 29/191(15.2%), intensive 23/188(12.2%), rate ratio 0.81 ...