OophorectomyNCT01007305
Bilateral Oophorectomy Versus Ovarian Conservation
A study testing Bilateral salpingo-oophorectomy and Ovarian conservation in people with Oophorectomy and Hysterectomy, run by University of California, San Francisco at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Oophorectomy, Hysterectomy
- What is being tested?
- Bilateral salpingo-oophorectomy and Ovarian conservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama
University of California, Sans Francisco
San Francisco, California, 94115
About this study
Official title: Elective Bilateral Salpingo-oophorectomy Versus Ovarian Conservation: A Pilot Randomized, Controlled Trial
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
- Being tested
- Bilateral salpingo-oophorectomy, Ovarian conservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral salpingo-oophorectomyProcedure or surgery
Removal of both ovaries and fallopian tubes at the time of hysterectomy
Ovarian conservationProcedure or surgery
Both ovaries and fallopian tubes not removed at the time of hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Bilateral salpingo-oophorectomy | Experimental | Removal of both ovaries and fallopian tubes at the time of hysterectomy for benign conditions. Receives: Procedure: Bilateral salpingo-oophorectomy |
| Ovarian conservation | Active comparator | No ovaries or fallopian tubes removed at the time of hysterectomy for benign conditions. Receives: Procedure: Ovarian conservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Measured: start of study
Flow-mediated diameter of the brachial artery
Measured: Baseline and 6 months follow-up
Serum bone turnover markers
Measured: Baseline and 6 months follow-up
Sexual functioning and quality-of-life questionnaires
Measured: Baseline and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OophorectomyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007305
- Sponsor's protocol ID
- BSO 01
- Status last verified
- Nov 2009
- First submitted
- 3 Nov 2009
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elective Bilateral Salpingo-oophorectomy Versus Ovarian Conservation: A Pilot Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01007305
- Acronym / sponsor ID
- BSO 01
- Conditions
- Oophorectomy, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- May 2009
- Primary completion
- Apr 2011 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral salpingo-oophorectomy | Experimental | Procedure: Bilateral salpingo-oophorectomyRemoval of both ovaries and fallopian tubes at the time of hysterectomy for benign conditions. |
| Ovarian conservation | Active comparator | Procedure: Ovarian conservationNo ovaries or fallopian tubes removed at the time of hysterectomy for benign conditions. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral salpingo-oophorectomyRemoval of both ovaries and fallopian tubes at the time of hysterectomy | Procedure or surgery | Bilateral salpingo-oophorectomy |
| Ovarian conservationBoth ovaries and fallopian tubes not removed at the time of hysterectomy | Procedure or surgery | Ovarian conservation |
Primary outcome
Recruitment rate
Time frame: start of study
Flow-mediated diameter of the brachial artery
Time frame: Baseline and 6 months follow-up
Serum bone turnover markers
Time frame: Baseline and 6 months follow-up
Sexual functioning and quality-of-life questionnaires
Time frame: Baseline and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral salpingo-oophorectomy and Ovarian conservation in people with Oophorectomy and Hysterectomy, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: start of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2011.