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Recruiting NCT04151433

NCT04151433 Conservative Endometrioma Surgery

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Clinical Trial Summary
NCT ID NCT04151433
Status Recruiting
Phase
Sponsor Universitaire Ziekenhuizen KU Leuven
Condition Endometriosis Ovary
Study Type INTERVENTIONAL
Enrollment 92 participants
Start Date 2019-10-24
Primary Completion 2024-12

Trial Parameters

Condition Endometriosis Ovary
Sponsor Universitaire Ziekenhuizen KU Leuven
Study Type INTERVENTIONAL
Phase N/A
Enrollment 92
Sex FEMALE
Min Age 18 Years
Max Age 40 Years
Start Date 2019-10-24
Completion 2024-12
Interventions
Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

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Brief Summary

To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation. The 2 conservatives techniques used are: 1. The combined technique 2. CO2 laser vaporization only Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.

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

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