The Therapy of Large Endometrioma

Endometrioma Clinical Trial

— ENDOKYSTE  

Official title:

Evaluate the Therapy of Large Ovarian Endometrioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04704115
• Other study ID #: 2019_43
• Secondary ID: 2020-A02354-35
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Endometriosis Ovary

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