Conservative Endometrioma Surgery
Recruiting · NCT04151433 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitaire Ziekenhuizen KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).
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.
Who can take part
Age range
18 Years to 40 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed.
- GZA Sint-Augustinus - Antwerp, Belgium
- Cliniques universitaires Saint-LUC (UCL) - Brussels, Belgium
- UZLeuven - Leuven, Belgium
- CHR La Citadelle - Liège, Belgium