NCT01007305

Bilateral Oophorectomy Versus Ovarian Conservation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Bilateral salpingo-oophorectomy	Removal of both ovaries and fallopian tubes at the time of hysterectomy
PROCEDURE	Ovarian conservation	Both ovaries and fallopian tubes not removed at the time of hysterectomy

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-04-01
• First posted: 2009-11-04
• Last updated: 2011-08-05

Locations

2 sites across 1 country: United States