Ovarian EndometriomaPhase 3NCT00989118
Randomized Study on Endometrioma Treatment
A Phase 3 study testing Laser treatment of ovarian endometrioma in people with Ovarian Endometrioma, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Endometrioma
- What is being tested?
- Laser treatment of ovarian endometrioma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- May 2000to Mar 2004
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 40 years
- uni or bilateral symptomatic endometriotic cysts with a minimum diameter of 30 millimetres
- no counter-indication for the use of GnRH analogues
Who cannot join
- previous pelvic surgeries
- history of cancer
- suspected malignancy
- presurgical suspicion or evidence of deep endometriosis
- presurgical suspicion or evidence of premature ovarian failure
- use of oestrogen suppressive drugs in the preceding 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.
- Conditions
- Ovarian Endometrioma
- Being tested
- Laser treatment of ovarian endometrioma
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatment of ovarian endometriomaProcedure or surgery
Laser vaporization of ovarian endometrioma
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Not described Receives: Procedure: Laser treatment of ovarian endometrioma |
| Endometrioma cystectomy | Active comparator | Not described Receives: Procedure: Laser treatment of ovarian endometrioma |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startMay 2000
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989118
- Sponsor's protocol ID
- endometriomatreatment
- Status last verified
- Oct 2009
- First submitted
- 1 Oct 2009
- Last updated
- 2 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Carmona F, Martinez-Zamora MA, Rabanal A, Martinez-Roman S, Balasch J. Ovarian cystectomy versus laser vaporization in the treatment of ovarian endometriomas: a randomized clinical trial with a five-year follow-up. Fertil Steril. 2011 Jul;96(1):251-4. doi: 10.1016/j.fertnstert.2011.04.068. Epub 2011 May 14.
PubMed 21575941
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on Endometrioma Treatment
- ClinicalTrials.gov ID
- NCT00989118
- Acronym / sponsor ID
- endometriomatreatment
- Conditions
- Ovarian Endometrioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- May 2000
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 2 Oct 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 randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.
Study design
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Procedure: Laser treatment of ovarian endometrioma |
| Endometrioma cystectomy | Active comparator | Procedure: Laser treatment of ovarian endometrioma |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 and 40 years
- uni or bilateral symptomatic endometriotic cysts with a minimum diameter of 30 millimetres
- no counter-indication for the use of GnRH analogues
Key exclusion criteria (6 listed)
- previous pelvic surgeries
- history of cancer
- suspected malignancy
- presurgical suspicion or evidence of deep endometriosis
- presurgical suspicion or 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 |
|---|---|---|
| Laser treatment of ovarian endometriomaLaser vaporization of ovarian endometrioma | Procedure or surgery | Endometrioma cystectomy, Laser treatment |
Primary outcome
Not reported in the source record.
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 2 Oct 2009.
- Derived from this study: PubMed 21575941Carmona F, Martinez-Zamora MA, Rabanal A, Martinez-Roman S, Balasch J. Ovarian cystectomy versus laser vaporization in the treatment of ovarian endometriomas: a randomized clinical trial with a five-year follow-up. Fertil Steril. 2011 Jul;96(1):251-4. doi: 10.1016/j.fertnstert.2011.04.068. Epub 2011 May 14.
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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 Phase 3 study testing Laser treatment of ovarian endometrioma in people with Ovarian Endometrioma, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 3 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 2 Oct 2009. 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 Spain. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989118, which also lists 1 linked publication.
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 2 Oct 2009.