Status:
RECRUITING
Conservative Endometrioma Surgery
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
GZA Ziekenhuizen Campus Sint-Augustinus
Centre Hospitalier Régional de la Citadelle
Conditions:
Endometriosis Ovary
Endometrioma
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 ...
Eligibility 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
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04151433
Start Date
October 24 2019
End Date
December 1 2026
Last Update
December 10 2024
Active Locations (4)
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1
GZA Sint-Augustinus
Antwerp, Belgium, 2610
2
Cliniques universitaires Saint-LUC (UCL)
Brussels, Belgium
3
UZLeuven
Leuven, Belgium, 3000
4
CHR La Citadelle
Liège, Belgium, 4000