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Bilateral Oophorectomy Versus Ovarian Conservation

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01007305
First received: November 3, 2009
Last updated: August 4, 2011
Last verified: November 2009
History of Changes
  Purpose

This is a pilot study to assess the feasibility of conducting a randomized, blinded, controlled trial of bilateral salpingo-oophorectomy (BSO, removal of the ovaries and fallopian tubes) versus ovarian conservation among premenopausal women age 40 years and greater who plan to undergo hysterectomy for a benign gynecologic condition. Subjects will be randomized to BSO or ovarian conservation concomitant with hysterectomy and remain blinded to group assignment. The primary goal of this pilot is to determine the feasibility of recruiting and retaining study participants in anticipation of conducting a larger, multi-centered trial. However, the investigators will also obtain baseline data and follow-up measures at 6 weeks and 6 months after surgery. Outcomes will be assessed in several domains that the investigators hypothesize may be effected by oophorectomy: cardiovascular health, skeletal health, sexual functioning, and health-related quality-of-life.


Condition Intervention
Oophorectomy
Hysterectomy
 Procedure: Bilateral salpingo-oophorectomy
Procedure: Ovarian conservation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Elective Bilateral Salpingo-oophorectomy Versus Ovarian Conservation: A Pilot Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Recruitment rate [ Time Frame: start of study ] [ Designated as safety issue: No ]
  • Flow-mediated diameter of the brachial artery [ Time Frame: Baseline and 6 months follow-up ] [ Designated as safety issue: No ]
  • Serum bone turnover markers [ Time Frame: Baseline and 6 months follow-up ] [ Designated as safety issue: No ]
  • Sexual functioning and quality-of-life questionnaires [ Time Frame: Baseline and 6 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2009
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bilateral salpingo-oophorectomy
Removal of both ovaries and fallopian tubes at the time of hysterectomy for benign conditions.
 Procedure: Bilateral salpingo-oophorectomy
Removal of both ovaries and fallopian tubes at the time of hysterectomy
Active Comparator: Ovarian conservation
No ovaries or fallopian tubes removed at the time of hysterectomy for benign conditions.
 Procedure: Ovarian conservation
Both ovaries and fallopian tubes not removed at the time of hysterectomy

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Plans to undergo hysterectomy for any non-cancerous gynecologic condition, including symptomatic fibroids, abnormal bleeding, pelvic pain, or pelvic organ prolapse. Hysterectomy may be done abdominally, vaginally or laparoscopically
  2. Premenopausal defined as having at least one menses in the 3 months prior to surgery
  3. Age > or = 40 years
  4. Speaks English or Spanish

Exclusion Criteria:

  1. Personal or family history of breast and/or ovarian cancer (at least one first degree relative with a diagnosis of breast or ovarian cancer) or a known BRCA mutation
  2. Known or suspected adnexal mass by physical exam or radiologic imaging study
  3. Gynecologist recommends BSO for treatment of pelvic pain and/or endometriosis
  4. Known history of coronary heart disease defined as any of the following: prior myocardial infarction, history of angioplasty, history of angina, admission to the hospital for evaluation of chest pain, or use of nitroglycerin to treat angina
  5. History of stroke
  6. History of osteoporosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007305

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, California
University of California, Sans Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Vanessa L. Jacoby, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01007305     History of Changes
Other Study ID Numbers: BSO 01
Study First Received: November 3, 2009
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013