Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT04151433

Conservative Endometrioma Surgery

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-12-10

92

Participants Needed

4

Research Sites

370 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

G

GZA Ziekenhuizen Campus Sint-Augustinus

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Conservative Endometrioma Surgery

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 40 years
  • Unilateral endometriotic cyst measuring between 2.5 cm and 8 cm in three dimensions
  • Contralateral endometrioma of 2 cm or less allowed
  • Complaints of infertility and/or pain
  • Body mass index (BMI) of 35 or lower
  • Use of combined or progesterone-only contraception for at least 4 weeks before surgery
Not Eligible

You will not qualify if you...

  • Incomplete pelvic surgery
  • Contraindication to combined or progesterone-only contraception
  • Use of GnRH analogues before and within 3 months after surgery
  • History of hysterectomy
  • Prior unilateral oophorectomy
  • Pituitary or hypothalamic disorders
  • Suspected malignancy
  • Contralateral endometrioma larger than 2 cm
  • Preoperative AMH level below 0.7
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

GZA Sint-Augustinus

Antwerp, Belgium, 2610

Actively Recruiting

2

Cliniques universitaires Saint-LUC (UCL)

Brussels, Belgium

Actively Recruiting

3

UZLeuven

Leuven, Belgium, 3000

Actively Recruiting

4

CHR La Citadelle

Liège, Belgium, 4000

Actively Recruiting

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Research Team

C

Carla Tomassetti, MD, PhD

CONTACT

C

Celine Bafort, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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