Ascertaining Longterm Outcomes of Fibroid Treatments

Running, not enrolling

Conditions studied: Uterine Fibroid

In brief

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.

Key facts

Study ID

NCT06430320

Run by

Henry Ford Health System

People needed

700

Starts

2024-05-20

Expected to finish

2027-08-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Henry Ford Health — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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