Bilateral Oophorectomy Versus Ovarian Conservation

Study Overview
=================
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.

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

Conditions
-----------------
Oophorectomy, Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Bilateral salpingo-oophorectomy
* Procedure: Ovarian conservation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Premenopausal defined as having at least one menses in the 3 months prior to surgery Age > or = 40 years Speaks English or Spanish Exclusion Criteria: 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 Known or suspected adnexal mass by physical exam or radiologic imaging study Gynecologist recommends BSO for treatment of pelvic pain and/or endometriosis 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 History of stroke History of osteoporosis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral salpingo-oophorectomy<br>Removal of both ovaries and fallopian tubes at the time of hysterectomy for benign conditions. | Procedure: Bilateral salpingo-oophorectomy<br>* Removal of both ovaries and fallopian tubes at the time of hysterectomy<br>|
| Active Comparator: Ovarian conservation<br>No ovaries or fallopian tubes removed at the time of hysterectomy for benign conditions. | Procedure: Ovarian conservation<br>* Both ovaries and fallopian tubes not removed at the time of hysterectomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |