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The Therapy of Large Endometrioma (ENDOKYSTE)

U

University Hospital, Lille

Status

Enrolling

Conditions

Endometriosis Ovary
Endometrioma

Study type

Observational

Funder types

Other

Identifiers

NCT04704115
2020-A02354-35 (Other Identifier)
2019_43

Details and patient eligibility

About

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

Enrollment

62 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Chrytèle RUBOD, MD,PhD

Data sourced from clinicaltrials.gov

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