NCT06430320

Ascertaining Longterm Outcomes of Fibroid Treatments

Long Term Effectiveness of Uterine Sparing Fibroid Treatments

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroid

Interventions

Type	Name	Description
OTHER	NA- no intervention	NA- no intervention

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-03-31
• Completion: 2027-08-01
• First posted: 2024-05-28
• Last updated: 2025-05-14

Locations

4 sites across 1 country: United States