Ovarian EndometriomaNCT02350452
Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Endometriomas
A study testing Diode laser coagulation and Bipolar coagulation in people with Ovarian Endometrioma, run by University of Cagliari at 1 site in Italy.
Trial summary
Endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques. The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular count (AFC) , with the most common serological markers of ovarian… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Endometrioma
- What is being tested?
- Diode laser coagulation and Bipolar coagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Feb 2016
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- regular menstrual cycles
- unilateral endometrioma greater than 35 mm
- no gynecological surgery 3-6 months before surgery
- no hormonal therapy 1 month before surgery
Who cannot join
- previous surgery for endometriosis
- hormone therapy in the month before the current surgery
- coagulation disorders
- ongoing pregnancy
- pelvic inflammatory disease
- malignant disorders
Show all 11Show fewer
- cysts otherwise
- Gonadotropin-releasing hormone analogues or contraceptive therapy during the follow-up
- BMI≥ 30 kg/m2
- endocrinological disorders
- unable or unwilling to give written consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Cagliari,Obstetrics and Gynecological Department,
Monserrato, Cagliari, 09042
About this study
Official title: The Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Inner Lining of Ovarian Endometriomas After Laparoscopic Cystectomy: a Randomized Clinical Trial.
Endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques.
The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular count (AFC) , with the most common serological markers of ovarian reserve. The investigators intend to confirm their clinical utility in the assessment of ovarian function, and to promote their use in predicting decreased ovarian reserve.
The work therefore moreover arises the objective to validate the bibliographic data about using the laser for haemostasis after stripping endometriomas, to amplify knowledge available in the literature on the surgical treatment of ovarian endometriomas and on the diode laser application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the possible surgical implications on fertility .
- Conditions
- Ovarian Endometrioma
- Being tested
- Diode laser coagulation, Bipolar coagulation
- Keywords
- laparoscopic surgery, diode laser, AMH, AFC
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser coagulationProcedure or surgery
Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Bipolar coagulationProcedure or surgery
Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
| Study group | Role | What they receive |
|---|---|---|
| Diode laser coagulation | Experimental | Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy Receives: Procedure: Diode laser coagulation |
| Bipolar coaugulation | Active comparator | Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy Receives: Procedure: Bipolar coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Müllerian hormone (AMH) serum levels
Measured: Change from AMH serum levels at 3 months after surgery
Secondary outcomes (1)
Antral follicular count (AFC)
Measured: Change from AFC at 3 months after surgery, during early follicular phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian EndometriomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Foggia
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350452
- Sponsor's protocol ID
- ENDOLASER01
- Status last verified
- Apr 2016
- First submitted
- 19 Jan 2015
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Inner Lining of Ovarian Endometriomas After Laparoscopic Cystectomy: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02350452
- Acronym / sponsor ID
- ENDOLASER01
- Conditions
- Ovarian Endometrioma
- Keywords
- laparoscopic surgery, diode laser, AMH, AFC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- University of Foggia
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jan 2015 (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.
Endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques.
The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular count (AFC) , with the most common serological markers of ovarian reserve. The investigators intend to confirm their clinical utility in the assessment of ovarian function, and to promote their use in predicting decreased ovarian reserve.
The work therefore moreover arises the objective to validate the bibliographic data about using the laser for haemostasis after stripping endometriomas, to amplify knowledge available in the literature on the surgical treatment of ovarian endometriomas and on the diode laser application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the possible surgical implications on fertility .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode laser coagulation | Experimental | Procedure: Diode laser coagulationDiode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy |
| Bipolar coaugulation | Active comparator | Procedure: Bipolar coagulationBipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- regular menstrual cycles
- unilateral endometrioma greater than 35 mm
- no gynecological surgery 3-6 months before surgery
- no hormonal therapy 1 month before surgery
Key exclusion criteria (11 listed)
- previous surgery for endometriosis
- hormone therapy in the month before the current surgery
- coagulation disorders
- ongoing pregnancy
- pelvic inflammatory disease
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 |
|---|---|---|
| Diode laser coagulationDiode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy | Procedure or surgery | Diode laser coagulation |
| Bipolar coagulationBipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy | Procedure or surgery | Bipolar coaugulation |
Primary outcome
Anti-Müllerian hormone (AMH) serum levels
Time frame: Change from AMH serum levels at 3 months after surgery
1 secondary outcome
Antral follicular count (AFC)
Time frame: Change from AFC at 3 months after surgery, during early follicular phase
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 22 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser coagulation and Bipolar coagulation in people with Ovarian Endometrioma, run by University of Cagliari at 1 site in Italy.
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 11 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 22 Apr 2016. 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 Italy. 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?
Anti-Müllerian hormone (AMH) serum levels (time frame: Change from AMH serum levels at 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 22 Apr 2016.