What side effects are associated with this type of intervention?

Lifestyle interventions for female infertility, such as those in the Fit-For-Fertility Program, generally have minimal side effects, including temporary discomfort or fatigue. Medical treatments like clomiphene citrate can cause hot flashes, bloating, and mood swings. Metformin may lead to gastrointestinal issues like nausea and diarrhea. Dopamine agonists such as bromocriptine and cabergoline can cause headaches, dizziness, and gastrointestinal discomfort. Overall, lifestyle changes are low-risk compared to medical treatments, which have more pronounced side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for female infertility, including medications like clomiphene citrate and metformin, which are often used to induce ovulation in women with conditions like polycystic ovary syndrome (PCOS). Clomiphene citrate is a selective estrogen receptor modulator that increases the release of hormones necessary for ovulation. Metformin, an insulin-sensitizing agent, is used to improve menstrual cyclicity and ovulation in women with PCOS. While lifestyle changes such as weight management, diet, and exercise are not directly FDA-approved treatments, they are strongly recommended by healthcare providers as they can significantly improve fertility outcomes, particularly in obese women. The Fit-For-Fertility Program aims to integrate these lifestyle modifications with standard fertility treatments to enhance the chances of conception and healthy pregnancy.

What other types of research exist?

<ol> <li>Mobile Health Coaching Programs: Programs like Smarter Pregnancy, which provide personalized coaching on nutrition and lifestyle behaviors through mobile health platforms, have shown potential in improving pregnancy rates and are cost-effective.</li> <li>Ovulation Induction with Letrozole: Letrozole is now suggested as a first-line therapy for oligo-ovulatory women with PCOS, showing better outcomes compared to clomiphene citrate.</li> <li>Metformin for PCOS: Metformin, especially when combined with lifestyle modifications, can improve menstrual cyclicity and spontaneous ovulation in women with PCOS.</li> <li>Acupuncture: Some studies suggest that acupuncture may improve ovulation and fertility outcomes in women with PCOS.</li> <li>Laparoscopic Ovarian Drilling: For clomiphene-resistant PCOS patients, laparoscopic ovarian drilling has been shown to improve ovulation and fertility outcomes.</li> </ol>

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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

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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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

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

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.

0 / 4Eligibility criteria met

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.