Ascertaining Longterm Outcomes of Fibroid Treatments (ALOFT)

Henry Ford Health

Status: Invitation-only

Conditions: Uterine Fibroid

Treatments: Other: NA- no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06430320

R9NXPE2GTCN9

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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