Fast Track to Fertility for Infertility

(FTFRCT Trial)

Overseen By Benjamin J Peipert, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Age <18, Non-English, others

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

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the Fast Track to Fertility Algorithmic Text Messaging Platform can accelerate infertility diagnosis. The platform sends personalized text prompts and educational videos on topics such as fertility tests, nutrition, and lifestyle changes. It targets new female patients at Penn Fertility Care who have not completed at least three key components of their fertility testing, such as blood tests or pelvic ultrasounds. Participants will be randomly assigned to use either the new platform or the standard information materials. As an unphased trial, this study provides participants the chance to contribute to innovative research that could improve fertility care for future patients.

Do I need to stop my current medications for this trial?

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 this protocol is safe for improving fertility workup efficiency?

Research shows that the Fast Track to Fertility program uses text messages and videos to help people understand and complete fertility tests more quickly. The program involves no new medicines or medical procedures, so typical drug-related safety concerns, such as side effects, do not apply.

The main goal is to enhance communication and education for patients through digital tools. As it serves as a platform for sharing information rather than a medical treatment, safety risks remain very low. Participants receive messages and video links about fertility topics to aid in making informed decisions.

In simpler terms, joining this program is like using a health app that guides users through fertility issues. It focuses on providing information and reminders to support the fertility journey. Current research shows no safety risks associated with using this type of platform. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fast Track to Fertility Algorithmic Text Messaging Platform because it offers a personalized and interactive approach to fertility treatment. Unlike the traditional standard of care, which involves static printed or electronic materials, this platform uses algorithm-driven text messaging to guide patients through next steps and provide tailored educational content. It also includes engaging video links on crucial topics like menstrual cycles, nutrition, and mental health, potentially enhancing patient understanding and engagement. By leveraging technology to deliver timely and relevant information, this method aims to empower patients and optimize their fertility journey.

What evidence suggests that the Fast Track to Fertility program is effective for improving fertility workup efficiency?

Research has shown that the Fast Track to Fertility (FTF) program, which participants in this trial may receive, can significantly speed up the fertility testing process. Early results found that the program halved the time needed for diagnostic tests. Patients moved from their first appointment to starting treatment much faster, reducing the wait from over two months to just 41 days. The program uses text messages to remind patients about tests and share educational materials. These features help patients learn more and take charge of their care, making the process more efficient. ^{1 2 3 4 6}

Who Is on the Research Team?

Anuja Dokras, MD, MHCI, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

The Fast Track to Fertility trial is for individuals experiencing infertility who are undergoing a fertility workup. The study aims to include participants willing to use an algorithmic text messaging platform with educational videos designed to expedite and enhance their diagnostic process.

Inclusion Criteria

I am willing to be assigned randomly to a new treatment or the usual treatment.

I am a new female patient at Penn Fertility Care for infertility tests.

I haven't completed major parts of fertility testing.

Exclusion Criteria

Pregnancy

Patients with no access to texting or unable to engage via a text messaging service

Patients requiring fewer than three components of the infertility work-up

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Work-up

Participants undergo a personalized fertility diagnostic work-up including laboratory tests, imaging, and genetic screening

60 days

Multiple visits as required for testing

Treatment Initiation

Participants begin fertility treatment based on diagnostic work-up results

Varies based on treatment plan

Follow-up

Participants are monitored for treatment effectiveness and pregnancy outcomes

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fast Track to Fertility Algorithmic Text Messaging Platform

Trial Overview This trial tests the 'Fast Track to Fertility v2.0 Program', which combines text messaging and educational videos, against standard procedures. It's a randomized controlled initiative measuring how well the program improves time efficiency, completion rates, and patient knowledge during fertility workups.

How Is the Trial Designed?

Group I: Fast Track to Fertility Algorithmic Text Messaging Platform Experimental Treatment 1 Intervention

Patients randomized to the FTF arm will have a personalized algorithm selected on the W2H platform to send text messaging prompts about the next steps and provide educational materials. Patients in this arm will also receive text links to educational videos on the following subjects: * Diagnostic testing * Fertility awareness methods * Menstrual cycle * Optimizing natural fertility * Nutrition * Lifestyle modifications * Supplements * COVID and fertility * Mental health and fertility

Group II: Standard of Care Active Control 1 Intervention

Patients randomized to the standard of care receive printed and/or electronic information about diagnostic tests and infertility treatments. A link to all video patient educational materials is included in this printed/electronic information. These educational materials will be provided at the first patient visit.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07154888

Study Details | NCT07154888 | Fast Track to Fertility The initial pilot program resulted in an approximately 50% reduction in the time taken to complete the diagnostic workup.

2. chti.upenn.edu chti.upenn.edu/fast-track-to-fertility

Fast Track to Fertility Fast Track to Fertility is a novel care delivery model that introduces a digital front door to improve access to fertility care.

3. pennmedicine.org pennmedicine.org/news/fast-track-to-fertility-program-sharply-cuts-time-to-treatment

Fast track to fertility program sharply cuts time to treatment A telemedicine-driven program cut the time from an initial new patient visit to fertility treatment from more than two months to 41 days.

4. fertstert.org fertstert.org/article/S0015-0282(23)00301-1/pdf

Barriers to access: findings from an implementation study ... The Fast Track to Fertility (FTF) program uses semiautomated 2-way text messages to send reminders regarding the timings of tests, the location of testing sites ...

5. nature.com nature.com/articles/s41746-024-01006-x

The prospect of artificial intelligence to personalize ... A recent 'Fast Track to Fertility' program using semi-automated two-way text messages reduced the time to complete a workup by 50%6.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12340364/

A qualitative analysis of fertility tracker marketing We demonstrate how company marketing encourages users to centre digital tracking technologies in their fertility journeys. In doing so, Femtech ...