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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04704115
Other study ID # 2019_43
Secondary ID 2020-A02354-35
Status Recruiting
Phase
First received
Last updated
Start date January 21, 2021
Est. completion date September 2023

Study information

Verified date January 2023
Source University Hospital, Lille
Contact Chrytèle RUBOD, MD,PhD
Phone 0320445962
Email chrystele.rubod@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hop Jeanne de Flandre Chu Lille Lisle-sur-Tarn

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Recurrence of cyst = 3 cm determined by MRI or pelvic ultrasonography (US) at 3 months
Secondary The impact of the ovarian reserve postoperative Compare the dosages of anti-mullerian hormone (AMH) preoperative and postoperative at 3 months at 3 months
Secondary The number of re-operation at 4 months
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