Conservative Endometrioma Surgery

Universitaire Ziekenhuizen KU Leuven92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometriosis Ovary Endometrioma

Interventions

Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).PROCEDURE

cf. different arms

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (4)

GZA Sint-Augustinus

Antwerp, Belgium

RECRUITING

Cliniques universitaires Saint-LUC (UCL)

Brussels, Belgium

RECRUITING

UZLeuven

Leuven, Belgium

RECRUITING

Outcomes

Primary Outcomes

AMH levels 3 months postoperatively

To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).

Time frame: 3 months postoperatively

Central Contacts

Carla Tomassetti, MD, PhD

CONTACT

+3216340825 carla.tomassetti@uzleuven.be

Celine Bafort, MD

CONTACT

+3216340088 celine.bafort@uzleuven.be

Data from ClinicalTrials.gov

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