AzTrials
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InfertilityFTFRCTNCT07154888

Fast Track to Fertility

A study testing Fast Track to Fertility Algorithmic Text Messaging Platform in people with Infertility, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Fast Track to Fertility (FTF) program is an algorithmic text messaging communication and patient education platform designed to improve the efficiency the fertility workup. The initial pilot program resulted in an approximately 50% reduction in the time taken to complete the diagnostic workup. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Infertility
What is being tested?
Fast Track to Fertility Algorithmic Text Messaging Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteUnited States
Study dates
25 Apr 2025to 20 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female new patients seen at Penn Fertility Care for the workup of infertility
  • Patients who have yet to complete at least 3 components of the fertility workup, including:
  • Laboratory blood tests
  • Tubal patency testing / uterine cavity assessment (hysterosalpingogram (HSG) or sonohysterogram (Femvue))
  • Pelvic ultrasound
  • Semen analysis
  • Genetic carrier screening.
  • Patients must be willing to be randomized to FTF versus standard of care

Who cannot join

  • Pregnancy
  • Age <18 years
  • 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
  • Patients presenting for second opinion with work-up completed
  • Patients seeking IVF for oocyte cryopreservation, PGT-M, or embryo banking
  • Non-English speaking

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Penn Fertility Care

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Fast Track to Fertility: Randomized Controlled Quality Improvement Initiative of an Algorithmic Text Messaging Communication and Patient Education Platform Designed to Improve the Efficiency the Fertility Workup

The Fast Track to Fertility (FTF) program is an algorithmic text messaging communication and patient education platform designed to improve the efficiency the fertility workup. The initial pilot program resulted in an approximately 50% reduction in the time taken to complete the diagnostic workup. Since the pilot program, the investigators have enhanced the FTF Program (v2.0) beyond the texting platform, incorporating educational videos to increase patient knowledge and autonomy in the workup and treatment of infertility. This protocol pertains to a randomized controlled quality improvement initiative to measure the impact of the FTF v2.0 Program on fertility workup completion, efficiency, and patient outcomes.

Read the detailed description

Infertility, recognized as a disease by the WHO, is defined as the failure to achieve successful pregnancy after at least 12 months of regular unprotected intercourse in women younger than age 35, or within 6 months in women 35 or older. The worldwide prevalence of infertility is high, affecting approximately 12-18% of couples. Through detailed medical history for risk factors, assessment of ovulatory function, structure and patency of the female reproductive tract, and semen analysis of the male partner, the cause of infertility can be ascertained in most patients and allows determination of appropriate therapeutic options.

Despite the high prevalence of infertility, only a small proportion of patients seek care, and an even smaller number continue care after the initial evaluation. Several studies have examined underlying reasons for early discontinuation of infertility care, namely prior to initiation of treatment. In a study from the Netherlands examining drop-out rates at different stages of fertility care, nearly half of the patients who discontinued care withdrew before initiating any treatment; 6.0% did not return after the first visit, 3.4% dropped out during the diagnostic work-up, and 35.7% dropped out after finishing the diagnostic workup. In a cohort of 434 infertile couples residing in urban United States, Eisenberg et al found that 13% did not pursue any infertility treatment after the initial consultation with a reproductive endocrinologist. When compared to patients pursuing treatment, these patients were typically older, less educated, of lower socioeconomic status, and had a higher baseline depression score. Of note, psychological factors are associated with higher drop-out rates even in patients with insurance coverage for infertility treatments. This data highlights that the initial evaluation and diagnostic work-up process is a critical stage of fertility care that engages patients and influences their decision to pursue treatment.

Although the barriers to pursuing fertility treatments have been studied, there is less information on the precise barriers to completing the diagnostic work-up. This first step can be cumbersome as it includes laboratory tests and radiographic or ultrasound imaging to evaluate the fallopian tube patency and uterine cavity in the female partner, blood tests and semen analysis in the male partner, and more recently, genetic carrier screening in both partners. What adds to the complexity of this testing is the need for time-sensitive and menstrual-cycle dependent testing which is required for the physician to recommend a personalized treatment plan. Poor communication or lack of understanding of the instructions can lead to missed testing windows, especially follicular phase appointments for blood tests and imaging studies. From a patient's perspective, each month that passes represents a missed opportunity to become pregnant further contributing to the higher levels of anxiety and stress associated with infertility diagnosis.

Based on contextual inquiry and grounded in patient needs, the work-up period was identified as an opportunity to optimize patient interactions with their physician. It was hypothesized that the implementation of a novel digital health platform to improve communication with patients regarding their diagnostic work-up will improve completion rates and overall patient retention. To this effect, the Fast Track to Fertility (FTF) program was created, which was developed using AI and natural language processing (NLP) to accurately provide semi-automated two-way text message communications to send reminders regarding the timing of tests, location of testing sites, and related educational materials. A detailed description of the discovery, pilot, and semi-automation phases of this innovative program has been published previously. A text-based approach was selected as it does not require downloading an app, supports real-time two-way engagement in a private setting, and has been shown to reduce racial disparities in care for reproductive-age women in our department.

The initial pilot program coupled with the iterative development phases resulted in an approximately 50% reduction in the time taken to complete the fertility work-up (from 97 days to 41 days) with high patient net promoter scores (>70%). In addition, high patient willingness to participate in this program (70%) and high accuracy of the AI-augmented texting (up to 80%) was observed, resulting in workflow improvement for staff and providers. However, it is not clear if these favorable outcomes were at least in part related to selection bias, as patients had to opt into the program and were not randomized. A secondary analysis on the barriers to infertility workup completion demonstrated that more Black women and those without fertility benefits both declined to enroll in the FTF program and did not initiate the infertility workup.

The goal of this proposed quality improvement initiative is to perform a randomized controlled quality improvement study on the updated FTF program (FTF v2.0). Since the initial pilot study was published, the FTF Program has been reworked. The platform now uses an algorithmic approach to text messaging (rather than AI) and incorporates several educational videos to increase patient knowledge and autonomy in the workup and treatment of infertility. Through this initiative, the aim is to measure the impact of the FTF program on infertility workup completion, fertility treatment initiation, pregnancy, and live birth.

Conditions
Infertility
Being tested
Fast Track to Fertility Algorithmic Text Messaging Platform
Keywords
infertility, text messaging, patient education
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fast Track to Fertility Algorithmic Text Messaging PlatformOther

    The Fast Track to Fertility algorithmic text messaging platform uses branching logic based on our standard workup protocol to text patients to schedule blood tests and an ultrasound timed to their menstrual cycle, as well as remind male partners to schedule blood and semen analyses.

    The platform will use an algorithmic approach to facilitate two-way communication, and any queries with no available responses will be escalated to the clinical team. Patients are not dependent on structured messages to progress through their journey; they can ask relevant questions in real time, and they are supported with fewer reminders. Response categories include clinical guidance and FAQs (e.g., how to determine cycle start or uterine cavity evaluation pre-appointment instructions), administrative guidance and FAQs (when to schedule test/appointment or clinic locations or phone numbers), and conversational pleasantries.

Study groups in NCT07154888
Study groupRoleWhat they receive
Fast Track to Fertility Algorithmic Text Messaging PlatformExperimentalPatients 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
Receives: Other: Fast Track to Fertility Algorithmic Text Messaging Platform
Standard of CareNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infertility workup completion

    Number of subjects that completed all components of their personalized work-up with 60 days of the new patient visit

    Measured: 60 days

Secondary outcomes (3)
  1. Days taken to complete the infertility workup

    Measured: One year following participant recruitment

  2. Days between new patient and return visit

    Measured: One year following participant recruitment

  3. Percentage of patients who completed 3, 4, or 5 components of the work-up

    Measured: One year following participant recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start25 Apr 2025
  3. Primary completion22 Oct 2025
  4. Study completion20 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154888
Sponsor's protocol ID
FTFRCT
Acronym
FTFRCT
Status last verified
Oct 2026
First submitted
30 Jun 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD that will be shared includes de-identified individual-level data related to primary and secondary outcome measures and baseline characteristics.

Publications

  • Acker A, Senapati S, Dokras A. Barriers to access: findings from an implementation study of an artificial intelligence-augmented 2-way chatbot for fertility care. Fertil Steril. 2023 Jul;120(1):199-201. doi: 10.1016/j.fertnstert.2023.04.016. Epub 2023 Apr 20. No abstract available.

    PubMed 37085095
  • Hirshberg A, Sammel MD, Srinivas SK. Text message remote monitoring reduced racial disparities in postpartum blood pressure ascertainment. Am J Obstet Gynecol. 2019 Sep;221(3):283-285. doi: 10.1016/j.ajog.2019.05.011. Epub 2019 May 20. No abstract available.

    PubMed 31121137
  • Lerma K, Reyes G, Tiwari S, Tewari A, Hastings C, Blumenthal PD. Acceptability of a text message-based fertility awareness application for family planning in Lucknow, India. Int J Gynaecol Obstet. 2018 Jul;142(1):104-107. doi: 10.1002/ijgo.12488. Epub 2018 Apr 6.

    PubMed 29574716
  • Senapati S, Asch DA, Merchant RM, Rosin R, Seltzer E, Mancheno C, et al. The Fast Track to Fertility Program: Rapid Cycle Innovation to Redesign Fertility Care. NEJM Catalyst 2022;3(10):CAT.22.0065.

  • Fallahzadeh H, Zareei Mahmood Abadi H, Momayyezi M, Malaki Moghadam H, Keyghobadi N. The comparison of depression and anxiety between fertile and infertile couples: A meta-analysis study. Int J Reprod Biomed. 2019 May 5;17(3):153-62. doi: 10.18502/ijrm.v17i3.4514. eCollection 2019 Mar.

    PubMed 31435599
  • Domar AD. Impact of psychological factors on dropout rates in insured infertility patients. Fertil Steril. 2004 Feb;81(2):271-3. doi: 10.1016/j.fertnstert.2003.08.013.

    PubMed 14967355
  • Eisenberg ML, Smith JF, Millstein SG, Nachtigall RD, Adler NE, Pasch LA, Katz PP; Infertility Outcomes Program Project Group. Predictors of not pursuing infertility treatment after an infertility diagnosis: examination of a prospective U.S. cohort. Fertil Steril. 2010 Nov;94(6):2369-71. doi: 10.1016/j.fertnstert.2010.03.068. Epub 2010 May 14.

    PubMed 20471010
  • Brandes M, van der Steen JO, Bokdam SB, Hamilton CJ, de Bruin JP, Nelen WL, Kremer JA. When and why do subfertile couples discontinue their fertility care? A longitudinal cohort study in a secondary care subfertility population. Hum Reprod. 2009 Dec;24(12):3127-35. doi: 10.1093/humrep/dep340. Epub 2009 Sep 26.

    PubMed 19783833
  • Thoma ME, McLain AC, Louis JF, King RB, Trumble AC, Sundaram R, Buck Louis GM. Prevalence of infertility in the United States as estimated by the current duration approach and a traditional constructed approach. Fertil Steril. 2013 Apr;99(5):1324-1331.e1. doi: 10.1016/j.fertnstert.2012.11.037. Epub 2013 Jan 3.

    PubMed 23290741
  • Practice Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Fertility evaluation of infertile women: a committee opinion. Fertil Steril. 2021 Nov;116(5):1255-1265. doi: 10.1016/j.fertnstert.2021.08.038. Epub 2021 Oct 2.

    PubMed 34607703
  • Practice Committee of the American Society for Reproductive Medicine. Electronic address: asrm@asrm.org. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2020 Mar;113(3):533-535. doi: 10.1016/j.fertnstert.2019.11.025. Epub 2020 Feb 27.

    PubMed 32115183
  • Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, Sullivan E, Vanderpoel S; International Committee for Monitoring Assisted Reproductive Technology; World Health Organization. International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology, 2009. Fertil Steril. 2009 Nov;92(5):1520-4. doi: 10.1016/j.fertnstert.2009.09.009. Epub 2009 Oct 14.

    PubMed 19828144

Questions about this trial

What is this clinical trial studying?

A study testing Fast Track to Fertility Algorithmic Text Messaging Platform in people with Infertility, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infertility workup completion (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154888, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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