- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04704115
The Therapy of Large Endometrioma (ENDOKYSTE)
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chrytèle RUBOD, MD,PhD
- Phone Number: +33 0320445962
- Email: chrystele.rubod@chru-lille.fr
Study Locations
-
-
-
Lisle-sur-Tarn, France, 59037
- Recruiting
- Hop Jeanne de Flandre Chu Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)
Time Frame: at 3 months
|
at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The impact of the ovarian reserve postoperative
Time Frame: at 3 months
|
Compare the dosages of anti-mullerian hormone (AMH) preoperative and postoperative at 3 months
|
at 3 months
|
The number of re-operation
Time Frame: at 4 months
|
at 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chrytèle RUBOD, MD,PhD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019_43
- 2020-A02354-35 (Other Identifier: ID-RCB number,ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endometrioma
-
Yonsei UniversityRecruiting
-
Hospital Clinic of BarcelonaCompleted
-
Yonsei UniversityUnknownUnilateral Ovarian EndometriomaKorea, Republic of
-
Plasma Surgical IncUnknown
-
Cairo UniversityUnknownOvarian EndometriomaEgypt
-
University of CagliariUniversity of FoggiaCompletedOvarian EndometriomaItaly
-
Medical University of ViennaRecruitingOvarian Endometrioma | Ovarian EndometriosisAustria
-
Shanghai First Maternity and Infant HospitalShanghai Tongji Hospital, Tongji University School of Medicine; International...RecruitingOvarian Reserve | Ovarian EndometriomaChina
-
Shaimaa Mostafa Mohammed Refaay El shemyCompletedOvarian EndometriomaEgypt
-
Uludag UniversityUnknownOvarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene ExpressionTurkey