Fast Track to Fertility

NCT07154888 | Active Not Recruiting

• 1 other identifier: FTFRCT
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infertility

Keywords

infertility; text messaging; patient education

Outcome Measures

Primary Outcomes (1)

• Infertility workup completion

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

  60 days

Secondary Outcomes (3)

• Days taken to complete the infertility workup

  One year following participant recruitment

• Days between new patient and return visit

  One year following participant recruitment

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

  One year following participant recruitment

Other Outcomes (5)

• Number of patients initiating any fertility treatment

  One year following participant recruitment

• Number of patients specifically initiating IVF

  One year following participant recruitment

• Time to initiate fertility treatment

  One year following participant recruitment

Study Arms (2)

Fast Track to Fertility Algorithmic Text Messaging Platform

EXPERIMENTAL

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

Other: Fast Track to Fertility Algorithmic Text Messaging Platform

Standard of Care

NO 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.

Interventions

Fast Track to Fertility Algorithmic Text Messaging Platform OTHER

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.

Fast Track to Fertility Algorithmic Text Messaging Platform

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Penn Fertility Care

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (12)

• 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.

  PMID: 37085095 BACKGROUND

• 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.

  PMID: 31121137 BACKGROUND

• 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.

  PMID: 29574716 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31435599 BACKGROUND

• 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.

  PMID: 14967355 BACKGROUND

• 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.

  PMID: 20471010 BACKGROUND

• 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.

  PMID: 19783833 BACKGROUND

• 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.

  PMID: 23290741 BACKGROUND

• 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.

  PMID: 34607703 BACKGROUND

• 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.

  PMID: 32115183 BACKGROUND

• 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.

  PMID: 19828144 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Anuja Dokras, MD, MHCI, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: September 4, 2025
• Study Start: April 25, 2025
• Primary Completion: October 22, 2025
• Study Completion (Estimated): April 25, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be made available beginning 6 months after publication and will be accessible for 2 years.
• Access Criteria: Data will be shared with qualified researchers upon request and with appropriate data use agreements. Interested researchers must submit a proposal outlining the research question and analysis plan.

Locations

US (1)