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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

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.


Condition or disease Intervention/treatment Phase
Endometrioma Procedure: Laparoscopic argon plasma treatment of endometrioma Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrioma Treatment and Ovarian Function
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Argon plasma
Patients with endometrioma treated with laparoscopic argon plasma energy.
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.

Experimental: Stripping and suture/coagulation
Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. Both ovarian volume [ Time Frame: 3 months, 1 year ]
    Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452123


Contacts
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Contact: Jan Humplik, MD 420377105254 humplikj@fnplzen.cz

Locations
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Czechia
Departement of gynecology and obstetrics, University hospital in Pilsen
Pilsen, Czechia, 30408
Contact: Jan Humplik, MD    420377105240    humplikj@fnplzen.cz   
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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Principal Investigator: Jan Humplik, MD Charles university in Pilsen
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Responsible Party: Jan Humplik, MD, Principal investigator, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT04452123    
Other Study ID Numbers: GPKENDO2001
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jan Humplik, MD, Charles University, Czech Republic:
Endometrioma
AMH
Additional relevant MeSH terms:
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Endometriosis