Bilateral Oophorectomy Versus Ovarian Conservation

NCT ID: NCT01007305

Last Updated: 2011-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31

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.

Conditions

Oophorectomy; Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Bilateral salpingo-oophorectomy

Removal of both ovaries and fallopian tubes at the time of hysterectomy for benign conditions.

Group Type: EXPERIMENTAL

Bilateral salpingo-oophorectomy

Intervention Type: PROCEDURE

Removal of both ovaries and fallopian tubes at the time of hysterectomy

Ovarian conservation

No ovaries or fallopian tubes removed at the time of hysterectomy for benign conditions.

Group Type: ACTIVE_COMPARATOR

Ovarian conservation

Intervention Type: PROCEDURE

Both ovaries and fallopian tubes not removed at the time of hysterectomy

Interventions

Bilateral salpingo-oophorectomy

Removal of both ovaries and fallopian tubes at the time of hysterectomy

Intervention Type: PROCEDURE

Ovarian conservation

Both ovaries and fallopian tubes not removed at the time of hysterectomy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

University of California, San Francisco

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California, Sans Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

BSO 01

Identifier Type: -

Identifier Source: org_study_id