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NCT Number: NCT04704115

The Therapy of Large 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

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Key information

Conditions

Endometrioma Disease Attributes Endometriosis Endometriosis Ovary Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lisle-sur-Tarn, 59037, France

Location status: Recruiting

Location contact

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)

    Time frame: at 3 months

Secondary outcomes

  1. 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

  2. The number of re-operation

    Time frame: at 4 months

Study contacts

Contact information is provided by the study sponsor or research team.

Chrytèle RUBOD, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Evaluate the Therapy of Large Ovarian Endometrioma

Acronym: ENDOKYSTE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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