Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04151433
Other study ID # S62899
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 24, 2019
Est. completion date December 2026

Study information

Verified date November 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact Carla Tomassetti, MD, PhD
Phone +3216340825
Email carla.tomassetti@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 92
Est. completion date December 2026
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).
cf. different arms

Locations

Country Name City State
Belgium GZA Sint-Augustinus Antwerp
Belgium Cliniques universitaires Saint-LUC (UCL) Brussel
Belgium UZLeuven Leuven
Belgium CHR La Citadelle Liège

Sponsors (4)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven Centre Hospitalier Régional de la Citadelle, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, GZA Ziekenhuizen Campus Sint-Augustinus

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary AMH levels 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). 3 months postoperatively
See also
  Status Clinical Trial Phase
Completed NCT01268930 - Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas N/A
Completed NCT05323539 - Comparison of Thyroid Volumes in Patients With and Without Endometrioma N/A
Recruiting NCT04178876 - Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS) N/A
Completed NCT06421857 - Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma N/A
Completed NCT01942122 - DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis Phase 2/Phase 3
Withdrawn NCT00999479 - Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation N/A
Recruiting NCT03687398 - Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls
Not yet recruiting NCT06377553 - PET/MRI for Evaluation of Endometriosis
Not yet recruiting NCT03788720 - Suture of the Ovary After Enucleation of Ovarian Endometrioma N/A
Completed NCT01982526 - Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients
Recruiting NCT05962775 - Ethanol Sclerotherapy Prior to ART N/A
Completed NCT03484546 - Optimum Menstrual Cycle Time for Endometrioma Excision
Completed NCT01808170 - Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve N/A
Recruiting NCT05637073 - Effect of Management of the Endometrioma on Ovarian Reserve
Completed NCT06219044 - Evaluation of Ovarian Reserve and Recurrence Rate After DWLS Diode Laser OMA Vaporization N/A
Recruiting NCT03620838 - Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial)
Terminated NCT03571776 - Anti-mullerian Hormone (AMH) After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial N/A
Enrolling by invitation NCT02472873 - Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas N/A
Completed NCT04941833 - Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo Phase 2/Phase 3
Completed NCT06274086 - Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma N/A