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Bilateral Oophorectomy Versus Ovarian Conservation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01007305
First Posted: November 4, 2009
Last Update Posted: August 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Alabama at Birmingham
Information provided by:
University of California, San Francisco
  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: Triple (Participant, 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:


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

Primary Outcome Measures:
  • Recruitment rate [ Time Frame: start of study ]
  • Flow-mediated diameter of the brachial artery [ Time Frame: Baseline and 6 months follow-up ]
  • Serum bone turnover markers [ Time Frame: Baseline and 6 months follow-up ]
  • Sexual functioning and quality-of-life questionnaires [ Time Frame: Baseline and 6 month follow-up ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Vanessa L. Jacoby, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01007305     History of Changes
Other Study ID Numbers: BSO 01
First Submitted: November 3, 2009
First Posted: November 4, 2009
Last Update Posted: August 5, 2011
Last Verified: November 2009