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Search / Trial NCT04151433

Conservative Endometrioma Surgery

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Oct 31, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating which surgical method is better for treating endometriomas—fluid-filled cysts that can form on the ovaries due to endometriosis—while also helping to preserve a woman's ability to have children in the future. The two surgical techniques being studied are a combined approach and using a CO2 laser for vaporization. Researchers will measure hormone levels (specifically AMH) before and after surgery to see how well each technique helps maintain ovarian reserve, which is the number of healthy eggs a woman has.

To participate in this trial, women aged 18 to 40 who are scheduled for laparoscopic surgery to treat endometriotic cysts may be eligible. They should have a cyst that is at least 2.5 cm but no larger than 8 cm, and they can have a smaller endometrioma on the other ovary. Women who are experiencing infertility or pain related to these cysts may find this study relevant. Participants can expect to undergo one of the two surgical techniques and will have their hormone levels checked as part of the study. This trial is currently recruiting participants, and it aims to provide valuable insights into the best way to manage endometriomas while considering future fertility.

Gender

FEMALE

Eligibility criteria

  • Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts.
  • Inclusion Criteria:
  • Age: 18 - 40 years (both inclusive)
  • Unilateral endometriotic cysts with a mean diameter of \>=2.5cm and ≤8 cm, measured in 3 dimensions.
  • Presence of a contralateral endometrioma of ≤ 2cm is allowed
  • Complaining of infertility and/or pain
  • BMI ≤35
  • Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery
  • Exclusion Criteria:
  • Incomplete surgery for the pelvis
  • Contra-indication for the use of contraception (combined or Progesteron only)
  • Use of GnRH analogues preoperatively and in the first 3 months postoperatively
  • (History of) hysterectomy
  • Prior unilateral oophorectomy
  • Pituitary/hypothalamic disorders
  • Suspected malignancy
  • Contralateral endometrioma of \>2 cm
  • AMH \<0.7 preoperatively
  • Pregnancy

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, , Belgium

Antwerp, , Belgium

Brussel, , Belgium

Liège, , Belgium

Patients applied

0 patients applied

Trial Officials

Carla Tomassetti, MD, PhD

Principal Investigator

Leuven University Fertility Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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