Endometrioma, Endometriosis Ovary
Conditions
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.
Interventions
PROCEDUREComparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).
cf. different arms
Sponsors
GZA Ziekenhuizen Campus Sint-Augustinus
Centre Hospitalier Régional de la Citadelle
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Belgium
Contacts
Primary ContactCarla Tomassetti, MD, PhD
Backup ContactCeline Bafort, MD
Outcome results
None listed