The Therapy of Large Endometrioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorUniversity Hospital, Lille
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Women presenting at a surgical consultation for the management of an endometrioma of 6cm or more
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)
Time frame
at 3 monthsSecondary outcomes
1
The impact of the ovarian reserve postoperative
Compare the dosages of anti-mullerian hormone (AMH) preoperative and postoperative at 3 months
Time frame
at 3 months2
The number of re-operation
Time frame
at 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov