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Endometrioma Treatment and Ovarian Function (EnTOF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452123
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Jan Humplik, MD, Charles University, Czech Republic

Tracking Information
First Submitted Date  ICMJE June 12, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date June 30, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2020)
  • AMH [ Time Frame: 3 days,3-5 week postop., 3 months postop., 1 year (optional) ]
    Changing of anti-müllerian hormon assay postop. in µg/L
  • Antral follicle count (AFC) [ Time Frame: 3 months, 1 year ]
    Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle
  • Both ovarian volume [ Time Frame: 3 months, 1 year ]
    Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endometrioma Treatment and Ovarian Function
Official Title  ICMJE Endometrioma Treatment and Ovarian Function
Brief Summary

Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is recommended when an endometrioma is more than 3 cm in diameter because this management is associated with better spontaneous conception rates. Nevertheless, surgery can also be potentially associated with a risk of destruction of functional ovarian tissue and reduction in ovarian reserve.

Anti-müllerian hormone (AMH) is a member of the Transforming Growth Factor beta family and is expressed by the small (<8 mm) pre-antral and early antral follicles. The AMH level reflects the size of the primordial follicle pool, and may be the best biochemical marker of ovarian function across an array of clinical situations Its level in serum is almost stable between 20 and 35 years of the woman´s life, unless using hormonal contraception and / or they suffer with Polycystic ovarian syndrome (PCOS). The level of AMH is also a useful indicator for the prediction chances of success of spontaneous or assisted conceptions. However, there paucity of data regarding changes in serum levels of AMH following surgery for endometrioma.

An alternative way for estimating ovarian reserve is quantifying ovarian mass with using standard 3D transvaginal ultrasound calculation (OVM) and assessment of antral follicular count.

The gold standard of endometrioma surgery is laparoscopic excision with suture or gentle coagulation of the rest of ovary or by the use of laparoscopic treatment with argon plasma energy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometrioma
Intervention  ICMJE
  • Procedure: Laparoscopic argon plasma treatment of endometrioma
    Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible
  • Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary
    Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.
Study Arms  ICMJE
  • Experimental: Argon plasma
    Patients with endometrioma treated with laparoscopic argon plasma energy.
    Interventions:
    • Procedure: Laparoscopic argon plasma treatment of endometrioma
    • Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary
  • Experimental: Stripping and suture/coagulation
    Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.
    Interventions:
    • Procedure: Laparoscopic argon plasma treatment of endometrioma
    • Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women with endometrioma 3cm and more in diameter

Exclusion Criteria:

  • using hormonal contraception or other hormonal treatment last 6 months
  • suffer with polycystic ovarian syndrome
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan Humplik, MD 420377105254 humplikj@fnplzen.cz
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452123
Other Study ID Numbers  ICMJE GPKENDO2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jan Humplik, MD, Charles University, Czech Republic
Study Sponsor  ICMJE Charles University, Czech Republic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Humplik, MD Charles university in Pilsen
PRS Account Charles University, Czech Republic
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP