Bilateral Oophorectomy Versus Ovarian Conservation

Not Applicable

Completed

• Conditions: Oophorectomy; Hysterectomy
• Interventions: Procedure: Bilateral salpingo-oophorectomy; Procedure: Ovarian conservation

• Registration Number: NCT01007305
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Status Verified: 2009-11
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Primary Completion: 2011-04
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral salpingo-oophorectomy	Bilateral salpingo-oophorectomy	Removal of both ovaries and fallopian tubes at the time of hysterectomy for benign conditions.
Ovarian conservation	Ovarian conservation	No ovaries or fallopian tubes removed at the time of hysterectomy for benign conditions.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University of California, Sans Francisco; 🇺🇸 San Francisco, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States