Ascertaining Longterm Outcomes of Fibroid Treatments

Long Term Effectiveness of Uterine Sparing Fibroid Treatments

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06430320

Acronym

ALOFT

Enrollment

700

Registered

2024-05-28

Start date

2024-05-20

Completion date

2027-08-01

Last updated

2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroid

Keywords

Uterine fibroid treatment, Multi-center, prospective, observational cohort study, Uterine-sparing treatment procedures, Patient-reported outcomes, Quality of life

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.

Interventions

OTHERNA- no intervention

NA- no intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Time to treatment failure	Up to 12 years	The need for another uterine fibroid treatment procedure

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGanesa Wegienka, PhD

Henry Ford Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026