Ascertaining Longterm Outcomes of Fibroid Treatments

• Conditions: Uterine Fibroid

• Registration Number: NCT06430320
• Lead Sponsor: Henry Ford Health System

Brief Summary

The goal of the ALOFT study is to understand the health of women in the 12 years following a uterine fibroid (UF) treatment. ALOFT is a multi-center, prospective, observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for UF and previously participated in the longitudinal studies COMPARE-UF (NCT02260752) or ULTRA (NCT02100904).

The primary uterine sparing treatment procedures undergone by study participants are myomectomy, endometrial ablation (EA), uterine artery embolization (UAE) and laparoscopic radiofrequency ablation (RFA). A smaller number of women may be studied who underwent focused ultrasound, intrauterine device (IUD), and medical management.

Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure. Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life.

The study's analyses will focus on comparisons of primary and secondary outcomes among women.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-20
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-28
• Primary Completion: 2025-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 700

Inclusion Criteria

• Participant has to have been enrolled in either the COMPARE-UF or ULTRA study
• Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study

Exclusion Criteria

• Individuals who were not consented into the original COMPARE-UF or ULTRA study
• Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to treatment failure	Up to 12 years	The need for another uterine fibroid treatment procedure

Trial Locations

Locations (4)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States