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Completed

NCT Number: NCT01007305

Bilateral Oophorectomy Versus Ovarian Conservation

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.

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Key information

Conditions

Oophorectomy Hysterectomy

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral Salpingo-Oophorectomy

Procedure

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

Ovarian conservation

Procedure

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

Primary outcomes

  1. Recruitment rate

    Time frame: start of study

  2. Flow-mediated diameter of the brachial artery

    Time frame: Baseline and 6 months follow-up

  3. Serum bone turnover markers

    Time frame: Baseline and 6 months follow-up

  4. Sexual functioning and quality-of-life questionnaires

    Time frame: Baseline and 6 month follow-up

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of Alabama at Birmingham

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
First posted
Nov 4, 2009
Registry last updated
Aug 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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