Ovarian CancerNCT01888159
Salpingectomy vs Tubal Sterilisation in Low Risk for Ovarian Cancer Women and Its Effect on Ovarian Reserve
A study testing Bilateral Salpingectomy and Tubal sterilization with bipolar energy in people with Ovarian Cancer, run by Karlstad Central Hospital at 1 site in Sweden.
Trial summary
Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Bilateral Salpingectomy and Tubal sterilization with bipolar energy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Sep 2014
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women seeking for tubal sterilisation
Who cannot join
- women older than 45
- family history of ovarian cancer
- presence of menopausal symptoms
- irregular cycles
- Hormone Replacement Therapy or hormone contraceptions the last 3 months
- history of previous ovarian or uterine surgeries
- imaging suggesting an ovarian cyst or other adnexal pathology during investigation
- previous salpingectomy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Obstetrics and Gynecology
Karlstad, Värmaland, 65185
About this study
Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve.
- Conditions
- Ovarian Cancer
- Being tested
- Bilateral Salpingectomy, Tubal sterilization with bipolar energy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral SalpingectomyProcedure or surgery
Tubal sterilization with bipolar energyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Tubal Sterilization with bipolar | Active comparator | Salpingectomy vs Tubal Sterilisation Receives: Procedure: Tubal sterilization with bipolar energy |
| Bilateral Salpingectomy | Active comparator | Salpingectomy vs Tubal Sterilisation Receives: Procedure: Bilateral Salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH)
Measured: 3 months
Secondary outcomes (3)
Anti-Mullerian hormone (AMH)
Measured: 1 year
Operative time
Measured: Postoperatively
Complications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karlstad Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonidas Magarakis, Karlstad Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888159
- Sponsor's protocol ID
- SEvsTSinAMH
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salpingectomy vs Tubal Sterilisation in Low Risk for Ovarian Cancer Women and Its Effect on Ovarian Reserve
- ClinicalTrials.gov ID
- NCT01888159
- Acronym / sponsor ID
- SEvsTSinAMH
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karlstad Central HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- First posted
- 27 Jun 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.
Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubal Sterilization with bipolar | Active comparator | Procedure: Tubal sterilization with bipolar energySalpingectomy vs Tubal Sterilisation |
| Bilateral Salpingectomy | Active comparator | Procedure: Bilateral SalpingectomySalpingectomy vs Tubal Sterilisation |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women seeking for tubal sterilisation
Key exclusion criteria (8 listed)
- women older than 45
- family history of ovarian cancer
- presence of menopausal symptoms
- irregular cycles
- Hormone Replacement Therapy or hormone contraceptions the last 3 months
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 Salpingectomy | Procedure or surgery | Bilateral Salpingectomy |
| Tubal sterilization with bipolar energy | Procedure or surgery | Tubal Sterilization with bipolar |
Primary outcome
Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH)
Time frame: 3 months
3 secondary outcomes
Anti-Mullerian hormone (AMH)
Time frame: 1 year
Operative time
Time frame: Postoperatively
Complications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Salpingectomy and Tubal sterilization with bipolar energy in people with Ovarian Cancer, run by Karlstad Central Hospital at 1 site in Sweden.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonidas Magarakis, MD (046737529929, lemagarakis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Mullerian hormone (AMH)and Follicle Stimulation Hormone (FSH) (time frame: 3 months). 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 27 Jun 2013.