EndometriomaENDOKYSTENCT04704115
The Therapy of Large Endometrioma
An observational study of Endometrioma and Endometriosis Ovary, run by University Hospital, Lille at 1 site in France.
Trial summary
Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve. Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometrioma, Endometriosis Ovary
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Women presenting at a surgical consultation for the management of an endometrioma of 6cm or more
Who may be able to join
- Endometrioma size ≥ 6cm determined by MRI or ultrasonography
- Women with isolated endometrioma or other extraovarian endometriosis: peritoneal, infiltrating endometriotic lesions and adenomyosis.
- Cyst single or bilateral
Who cannot join
- Cyst with radiographic or macroscopic in laparoscopy atypia
- Pregnancy
- Patient with contraindication to GnRH agonist (Enantone® 3,75 mg et Decapeptyl® 3 mg)
- Patient with contraindication to laparoscopy
- Patient with contraindication to general anesthesia
- Subject refusing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Jeanne de Flandre Chu Lille
Lisle-sur-Tarn, 59037
0320445962
About this study
Official title: Evaluate the Therapy of Large Ovarian Endometrioma
Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve.
Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve.
Read more
In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy.
This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above.
The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone
- Conditions
- Endometrioma, Endometriosis Ovary
- Keywords
- Endometriomas measuring 6 cm or more, Ovarian Endometrioma, laparoscopic drainage, recurrence, AMH, GnRH agonist therapy
- Medical subject headings
- Endometriosis, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)
Measured: at 3 months
Secondary outcomes (2)
The impact of the ovarian reserve postoperative
Compare the dosages of anti-mullerian hormone (AMH) preoperative and postoperative at 3 months
Measured: at 3 months
The number of re-operation
Measured: at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start21 Jan 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrytèle RUBOD, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704115
- Sponsor's protocol ID
- 2019_43
- Other IDs
- 2020-A02354-35
- Acronym
- ENDOKYSTE
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Therapy of Large Ovarian Endometrioma
- ClinicalTrials.gov ID
- NCT04704115
- Acronym / sponsor ID
- ENDOKYSTE / 2019_43
- Conditions
- Endometrioma, Endometriosis Ovary
- Keywords
- Endometriomas measuring 6 cm or more, Ovarian Endometrioma, laparoscopic drainage, recurrence, AMH, GnRH agonist therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jan 2021 (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.
Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve.
Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve.
In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy.
This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above.
The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women presenting at a surgical consultation for the management of an endometrioma of 6cm or more
Key inclusion criteria (3 listed)
- Endometrioma size ≥ 6cm determined by MRI or ultrasonography
- Women with isolated endometrioma or other extraovarian endometriosis: peritoneal, infiltrating endometriotic lesions and adenomyosis.
- Cyst single or bilateral
Key exclusion criteria (6 listed)
- Cyst with radiographic or macroscopic in laparoscopy atypia
- Pregnancy
- Patient with contraindication to GnRH agonist (Enantone® 3,75 mg et Decapeptyl® 3 mg)
- Patient with contraindication to laparoscopy
- Patient with contraindication to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)
Time frame: at 3 months
2 secondary outcomes
The impact of the ovarian reserve postoperative
Time frame: at 3 months
The number of re-operation
Time frame: at 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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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.
Chrytèle RUBOD, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrioma and Endometriosis Ovary, run by University Hospital, Lille at 1 site in France.
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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chrytèle RUBOD, MD,PhD (0320445962 ext. +33, chrystele.rubod@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US) (time frame: at 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 23 Dec 2025.