Bilateral Oophorectomy Versus Ovarian Conservation

University of California San Francisco (UCSF)

Status: Completed

Conditions: Hysterectomy; Oophorectomy

Treatments: Procedure: Ovarian conservation; Procedure: Bilateral salpingo-oophorectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01007305

BSO 01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Bilateral salpingo-oophorectomy

Experimental group

Description:

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

Treatment:

Procedure: Bilateral salpingo-oophorectomy

Ovarian conservation

Active Comparator group

Description:

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

Treatment:

Procedure: Ovarian conservation