Bilateral Oophorectomy Versus Ovarian Conservation

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01007305

Collaborator

University of Alabama at Birmingham (Other)

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oophorectomy Hysterectomy	Procedure: Bilateral salpingo-oophorectomy Procedure: Ovarian conservation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Apr 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States
2	University of California, Sans Francisco	San Francisco	California	United States	94115

Sponsors and Collaborators

University of California, San Francisco
University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01007305

Other Study ID Numbers:

BSO 01

First Posted:

Nov 4, 2009

Last Update Posted:

Aug 5, 2011

Last Verified:

Nov 1, 2009

Study Results

No Results Posted as of Aug 5, 2011