Bilateral Oophorectomy Versus Ovarian Conservation

Elective Bilateral Salpingo-oophorectomy Versus Ovarian Conservation: A Pilot Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy; Oophorectomy
• Intervention / Treatment: Procedure: Bilateral salpingo-oophorectomy; Procedure: Ovarian conservation

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • University of Alabama at Birmingham
  • California
    • San Francisco, California, United States, 94115
      • University of California, Sans Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): November 4, 2009

Study Record Updates

• Last Update Posted (Estimate): August 5, 2011
• Last Update Submitted That Met QC Criteria: August 4, 2011
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: BSO 01