Endometriosis OvaryNCT03826355
Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
A study testing CO2 (carbon dioxide) laser vaporisation and Stripping technique in people with Endometriosis Ovary, run by Hospital Clinic of Barcelona.
Trial summary
Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis Ovary
- What is being tested?
- CO2 (carbon dioxide) laser vaporisation and Stripping technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45.
- Bilateral endometriomas.
- Endometrioma size > 3 cm.
- Pain and/or infertility as indication to surgical treatment.
Who cannot join
- History of cancer.
- Suspected malignancy.
- Evidence of premature ovarian failure.
About this study
Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.
- Conditions
- Endometriosis Ovary
- Being tested
- CO2 (carbon dioxide) laser vaporisation, Stripping technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 (carbon dioxide) laser vaporisationProcedure or surgery
CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma
Stripping techniqueProcedure or surgery
Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue
| Study group | Role | What they receive |
|---|---|---|
| Stripping technique | Active comparator | The endometrioma is removed according to standard surgery. Receives: Procedure: Stripping technique |
| Laser technique | Experimental | The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser Receives: Procedure: CO2 (carbon dioxide) laser vaporisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve
Antral follicular count by ultrasound: number of antral follicles.
Measured: 7 months
Ovarian volume
Ovarian volume will be assesses by ultrasound, units given with milliliters
Measured: 7 months
Secondary outcomes (1)
Pregnancy rate
Pregnancy rate will be recorded during the 6 months follow-up
Measured: 6 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 posted1 Feb 2019
- Study startJan 2017
- Primary completionDec 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis OvaryStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Carmona, Hospital Clinic of Barcelona
- Investigators
- Francisco Carmona, MD PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826355
- Sponsor's protocol ID
- OR
- Status last verified
- Jan 2019
- First submitted
- 20 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
- ClinicalTrials.gov ID
- NCT03826355
- Acronym / sponsor ID
- OR
- Conditions
- Endometriosis Ovary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 1 Feb 2019 (actual)
- 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 disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
| Arm | Type | Receives |
|---|---|---|
| Stripping technique | Active comparator | Procedure: Stripping techniqueThe endometrioma is removed according to standard surgery. |
| Laser technique | Experimental | Procedure: CO2 (carbon dioxide) laser vaporisationThe endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 45.
- Bilateral endometriomas.
- Endometrioma size > 3 cm.
- Pain and/or infertility as indication to surgical treatment.
Key exclusion criteria (3 listed)
- History of cancer.
- Suspected malignancy.
- Evidence of premature ovarian failure.
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 |
|---|---|---|
| CO2 (carbon dioxide) laser vaporisationCO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma | Procedure or surgery | Laser technique |
| Stripping techniqueIdentification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue | Procedure or surgery | Stripping technique |
Primary outcome
Ovarian reserve
Time frame: 7 months
Antral follicular count by ultrasound: number of antral follicles.
Ovarian volume
Time frame: 7 months
Ovarian volume will be assesses by ultrasound, units given with milliliters
1 secondary outcome
Pregnancy rate
Time frame: 6 months after surgery
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 1 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Francisco Carmona, MD PhD principal investigator
Hospital Clinic of Barcelona
Questions about this trial
What is this clinical trial studying?
A study testing CO2 (carbon dioxide) laser vaporisation and Stripping technique in people with Endometriosis Ovary, run by Hospital Clinic of Barcelona.
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 3 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Ovarian reserve (time frame: 7 months). The study lists 2 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 1 Feb 2019.