Benign Uterine DiseasePhase 3NCT01893086
Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy
A Phase 3 study testing LH alone and LH with opportunistic salpingectomy in people with Benign Uterine Disease, run by CHA University at 3 sites in South Korea.
Trial summary
Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Read more about this study
- Who is it for?
- Ages 19 to 52 years, women only
- Conditions the study is for
- Benign Uterine Disease
- What is being tested?
- LH alone and LH with opportunistic salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jun 2013to Jul 2015
- Phase
- Phase 3
- 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 19 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women who were planning to undergo laparoscopic hysterectomy for benign uterine diseases
- women aged between 19 and 52 years
- women with regular menstruation (defined as the duration of menstrual cycle between 21 and 45 days)
- women who were appropriated medical status for laparoscopic surgery
Who cannot join
- any ovarian cysts requiring ovarian surgery
- any suspicious findings of malignant diseases
- history of prior salpingectomy or salpingo-oophorectomy
- pregnant or menopausal status
- preoperative serum anti-Müllerian hormone (AMH) < 0.30 ng/mL
- use of hormonal treatments in the three months before surgery
- any other endocrine disease (such as uncontrolled thyroid dysfunction, hyperprolactinemia, or Cushing syndrome)
- an inability to understand and provide written informed consent.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Keimyung University School of Medicine
Daegu, 700-712
Kangbuk Samsung Hospital
Seoul, 110-746
CHA Gangnam Medical Center
Seoul, 135-081
About this study
Official title: Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial
Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Therefore, the aim of this randomized controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.
- Conditions
- Benign Uterine Disease
- Being tested
- LH alone, LH with opportunistic salpingectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LH aloneProcedure or surgery
LH, laparoscopic hysterectomy
LH with opportunistic salpingectomyProcedure or surgery
LH, laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| LH alone | Active comparator | LH, laparoscopic hysterectomy Receives: Procedure: LH alone |
| LH with opportunistic salpingectomy | Experimental | LH, laparoscopic hysterectomy Receives: Procedure: LH with opportunistic salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ovarian reserve
The primary outcome measure was the change of ovarian reserve, determined by the rate of decline in AMH level from before surgery to 3-month post-surgery with the following formula : decline rate (%) = 100 × (preoperative AMH level - postoperative AMH level) ÷ preoperative AMH level.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Uterine DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, CHA University
- Investigators
- Taejong Song, MD PhD, Principal investigator, Kangbuk Samsung Hospital, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893086
- Sponsor's protocol ID
- KNC13-029
- Status last verified
- Jan 2016
- First submitted
- 2 Jul 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01893086
- Acronym / sponsor ID
- KNC13-029
- Conditions
- Benign Uterine Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Jul 2013 (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.
Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Therefore, the aim of this randomized controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LH alone | Active comparator | Procedure: LH aloneLH, laparoscopic hysterectomy |
| LH with opportunistic salpingectomy | Experimental | Procedure: LH with opportunistic salpingectomyLH, laparoscopic hysterectomy |
Who may qualify
- Ages
- 19 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women who were planning to undergo laparoscopic hysterectomy for benign uterine diseases
- women aged between 19 and 52 years
- women with regular menstruation (defined as the duration of menstrual cycle between 21 and 45 days)
- women who were appropriated medical status for laparoscopic surgery
Key exclusion criteria (8 listed)
- any ovarian cysts requiring ovarian surgery
- any suspicious findings of malignant diseases
- history of prior salpingectomy or salpingo-oophorectomy
- pregnant or menopausal status
- preoperative serum anti-Müllerian hormone (AMH) < 0.30 ng/mL
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 |
|---|---|---|
| LH aloneLH, laparoscopic hysterectomy | Procedure or surgery | LH alone |
| LH with opportunistic salpingectomyLH, laparoscopic hysterectomy | Procedure or surgery | LH with opportunistic salpingectomy |
Primary outcome
Change in ovarian reserve
Time frame: 3 months after surgery
The primary outcome measure was the change of ovarian reserve, determined by the rate of decline in AMH level from before surgery to 3-month post-surgery with the following formula : decline rate (%) = 100 × (preoperative AMH level - postoperative AMH level) ÷ preoperative AMH level.
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 28 Jan 2016.
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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.
Taejong Song, MD PhD principal investigator
Kangbuk Samsung Hospital, Seoul, Republic of Korea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LH alone and LH with opportunistic salpingectomy in people with Benign Uterine Disease, run by CHA University at 3 sites in South Korea.
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 8 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in ovarian reserve (time frame: 3 months after surgery). 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 28 Jan 2016.