Conservative Endometrioma Surgery

Not Applicable

Recruiting

• Conditions: Endometrioma; Endometriosis Ovary

• Registration Number: NCT04151433
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-24
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-05
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
AMH levels 3 months postoperatively	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).

Trial Locations

Locations (4)

GZA Sint-Augustinus; 🇧🇪 Antwerp, Belgium

Cliniques universitaires Saint-LUC (UCL); 🇧🇪 Brussel, Belgium

UZLeuven; 🇧🇪 Leuven, Belgium

CHR La Citadelle; 🇧🇪 Liège, Belgium