An observational study in Fibroids, Uterine, sponsored by Duke University. Completed at 9 sites in United States. Open to female participants aged 18 Years to 54 Years. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by Duke University · Observational
The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF.
Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.
COMPARE UF will enroll approximately 10,000 subjects across 9 clinical enrolling centers in the US. We anticipate recruitment to last approximately 24 months. Sites will consent interested patients and have them complete a patient contact information form to be used to contact the patient for telephone interviews. Following informed consent, the site will collect clinical information and several patient-reported outcomes scales, including the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL), the Menopausal Rating Scale, and the EQ-5D, a standardized measure of general health outcomes.
In year 01 of this study, among patients receiving a procedure to treat their UF, 1000 will be asked to provide two blood samples: the first at time of enrollment (before the procedure) and the second at 12 months after the procedure. Samples will be evaluated for ovarian reserve via a blood assay measurement of anti-mullerian hormone.
Additionally, for patients who have a procedure to treat their UF, they will have a routine clinic follow-up visit, sometime between 6 - 12 weeks post procedure. Additional clinical data will be collected at this time.
For patients who are treated medically, there will be no further study-related clinic visits. Follow-up will occur exclusively by telephone.
All consented patients will complete telephone interviews at approximately 12, 24, and 36 months following the initial procedure. It is anticipated that patients enrolled during the first study year will complete a maximum of three years of follow-up. However, if additional funds become available, the investigators plan to extend the follow-up of enrolled patients to five years.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 3,094 is above the median of 150 across 119 observational studies indexed under Leiomyoma.
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Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
10,000 patients diagnosed with UF between the ages of 18 and 54. Patients must have had a menstrual period within the last 12 months. Source documentation of UF must include either imaging or a pathology report.
Exclusion Criteria:
Patients who receive medical therapy only for treatment of their uterine fibroids
Drug: Medical Therapy
Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
Procedure: hysterectomy · Procedure: Uterine arterial embolization · Procedure: myomectomy · Procedure: endometrial ablation · Procedure: magnetic resonance guided focused ultrasound · Procedure: radiofrequency ablation
surgical removal of the uterus
In uterine artery embolization, doctor uses a slender, flexible tube (catheter) to inject small particles (embolic agents) into the uterine arteries, which supply blood to your fibroids and uterus.the embolic agents are injected into these fibroid blood vessels. The goal is to block the fibroid vessels, starving the fibroids and causing them to shrink and die.
Also known as: UAE
surgical procedure to remove uterine fibroids, but does not remove uterus
treatment of uterine fibroids with only medications, no procedure or surgery is used
surgical procedure that destroys uterine lining via a telescope placed inside the uterus
Also known as: NovaSure, Her Option, HydroTherm
procedure that destroys fibroids while inside an MRI machine
Also known as: MRgFUS, ExAblate; Sonalleve
procedure that uses heat to destroy uterine fibroids
Also known as: Accessa
change in symptom relief (patient interview)
degree to which bleeding and pain from uterine fibroids is alleviated
Time frame: 12, 24, 36 months
change in preservation reproductive function (patient interview)
ability of a woman after receiving treatment for uterine fibroids can conceive and deliver a healthy baby
Time frame: 12, 24, 36 months
Plan to share: Yes
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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