Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3094 participants
OBSERVATIONAL
2015-11-30
2020-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Medical
Patients who receive medical therapy only for treatment of their uterine fibroids
Medical Therapy
treatment of uterine fibroids with only medications, no procedure or surgery is used
Procedure
Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
hysterectomy
surgical removal of the uterus
Uterine arterial embolization
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.
myomectomy
surgical procedure to remove uterine fibroids, but does not remove uterus
endometrial ablation
surgical procedure that destroys uterine lining via a telescope placed inside the uterus
magnetic resonance guided focused ultrasound
procedure that destroys fibroids while inside an MRI machine
radiofrequency ablation
procedure that uses heat to destroy uterine fibroids
Interventions
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hysterectomy
surgical removal of the uterus
Uterine arterial embolization
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.
myomectomy
surgical procedure to remove uterine fibroids, but does not remove uterus
Medical Therapy
treatment of uterine fibroids with only medications, no procedure or surgery is used
endometrial ablation
surgical procedure that destroys uterine lining via a telescope placed inside the uterus
magnetic resonance guided focused ultrasound
procedure that destroys fibroids while inside an MRI machine
radiofrequency ablation
procedure that uses heat to destroy uterine fibroids
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Menstrual period within 12 months
Exclusion Criteria
* Men
* 55 years old or older
18 Years
54 Years
FEMALE
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Evan R Myers, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of California Medical Centers
San Francisco, California, United States
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Inova Health Systems
Falls Church, Virginia, United States
Countries
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References
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Anchan RM, Spies JB, Zhang S, Wojdyla D, Bortoletto P, Terry K, Disler E, Milne A, Gargiulo A, Petrozza J, Brook O, Srouji S, Morton CC, Greenberg J, Wegienka G, Stewart EA, Nicholson WK, Thomas L, Venable S, Laughlin-Tommaso S, Diamond MP, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL. Long-term health-related quality of life and symptom severity following hysterectomy, myomectomy, or uterine artery embolization for the treatment of symptomatic uterine fibroids. Am J Obstet Gynecol. 2023 Sep;229(3):275.e1-275.e17. doi: 10.1016/j.ajog.2023.05.020. Epub 2023 May 26.
Anchan RM, Wojdyla D, Bortoletto P, Terry K, Disler E, Milne A, Gargiulo A, Petrozza J, Brook O, Srouji S, Morton CC, Greenberg J, Wegienka G, Stewart EA, Nicholson WK, Thomas L, Venable S, Laughlin-Tommaso S, Diamond MP, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL, Spies JB. A Comparative Analysis of Health-Related Quality of Life 1 Year Following Myomectomy or Uterine Artery Embolization: Findings from the COMPARE-UF Registry. J Womens Health (Larchmt). 2023 Apr;32(4):423-433. doi: 10.1089/jwh.2022.0133. Epub 2023 Jan 13.
Wise LA, Thomas L, Anderson S, Baird DD, Anchan RM, Terry KL, Marsh EE, Wegienka G, Nicholson WK, Wallace K, Bigelow R, Spies J, Maxwell GL, Jacoby V, Myers ER, Stewart EA. Route of myomectomy and fertility: a prospective cohort study. Fertil Steril. 2022 May;117(5):1083-1093. doi: 10.1016/j.fertnstert.2022.01.013. Epub 2022 Feb 23.
Wallace K, Stewart EA, Wise LA, Nicholson WK, Parry JP, Zhang S, Laughlin-Tommaso S, Jacoby V, Anchan RM, Diamond MP, Venable S, Shiflett A, Wegienka GR, Maxwell GL, Wojdyla D, Myers ER, Marsh E. Anxiety, Depression, and Quality of Life After Procedural Intervention for Uterine Fibroids. J Womens Health (Larchmt). 2022 Mar;31(3):415-424. doi: 10.1089/jwh.2020.8915. Epub 2021 Jun 8.
Wegienka G, Stewart EA, Nicholson WK, Zhang S, Li F, Thomas L, Spies JB, Venable S, Laughlin-Tommaso S, Diamond MP, Anchan RM, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL. Black Women Are More Likely Than White Women to Schedule a Uterine-Sparing Treatment for Leiomyomas. J Womens Health (Larchmt). 2021 Mar;30(3):355-366. doi: 10.1089/jwh.2020.8634. Epub 2021 Feb 1.
Laughlin-Tommaso SK, Lu D, Thomas L, Diamond MP, Wallace K, Wegienka G, Vines AI, Anchan RM, Wang T, Maxwell GL, Jacoby V, Marsh EE, Spies JB, Nicholson WK, Stewart EA, Myers ER. Short-term quality of life after myomectomy for uterine fibroids from the COMPARE-UF Fibroid Registry. Am J Obstet Gynecol. 2020 Apr;222(4):345.e1-345.e22. doi: 10.1016/j.ajog.2019.09.052. Epub 2019 Oct 31.
Nicholson WK, Wegienka G, Zhang S, Wallace K, Stewart E, Laughlin-Tommaso S, Thomas L, Jacoby VL, Marsh EE, Wise L, Borah BJ, Spies J, Venable S, Anchan RM, Larry Maxwell G, Diamond M, Lytle B, Myers ER. Short-Term Health-Related Quality of Life After Hysterectomy Compared With Myomectomy for Symptomatic Leiomyomas. Obstet Gynecol. 2019 Aug;134(2):261-269. doi: 10.1097/AOG.0000000000003354.
Stewart EA, Lytle BL, Thomas L, Wegienka GR, Jacoby V, Diamond MP, Nicholson WK, Anchan RM, Venable S, Wallace K, Marsh EE, Maxwell GL, Borah BJ, Catherino WH, Myers ER. The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design. Am J Obstet Gynecol. 2018 Jul;219(1):95.e1-95.e10. doi: 10.1016/j.ajog.2018.05.004. Epub 2018 May 8.
Related Links
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COMPARE-UF Registry website
Additional research study HSRP20194228 "Methods for the Design and Conduct of Subgroup Analysis in Observational Studies"
Other Identifiers
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RFA-HS-14-006
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00057883
Identifier Type: -
Identifier Source: org_study_id