The Therapy of Large Endometrioma

NCT04704115 | Recruiting

• 2 other identifiers: 2019_432020-A02354-35
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Endometrioma; Endometriosis Ovary

Keywords

Endometriomas measuring 6 cm or more; Ovarian Endometrioma; laparoscopic drainage; recurrence; AMH; GnRH agonist therapy

Outcome Measures

Primary Outcomes (1)

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

  at 3 months

Secondary Outcomes (2)

• The impact of the ovarian reserve postoperative

  at 3 months

• The number of re-operation

  at 4 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women presenting at a surgical consultation for the management of an endometrioma of 6cm or more

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lisle-sur-Tarn, 59037, France

RECRUITING

MeSH Terms

Conditions

Endometriosis; Recurrence

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chrytèle RUBOD, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrytèle RUBOD, MD,PhD

CONTACT

0320445962; chrystele.rubod@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: January 21, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)