Endometrioma Treatment and Ovarian Function (EnTOF)
Primary Purpose
Endometrioma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Laparoscopic argon plasma treatment of endometrioma
Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary
Sponsored by
About this trial
This is an interventional treatment trial for Endometrioma focused on measuring Endometrioma, AMH
Eligibility 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
Sites / Locations
- Departement of gynecology and obstetrics, University hospital in Pilsen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Argon plasma
Stripping and suture/coagulation
Arm Description
Patients with endometrioma treated with laparoscopic argon plasma energy.
Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.
Outcomes
Primary Outcome Measures
AMH
Changing of anti-müllerian hormon assay postop. in µg/L
Antral follicle count (AFC)
Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle
Both ovarian volume
Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle
Secondary Outcome Measures
Full Information
NCT ID
NCT04452123
First Posted
June 12, 2020
Last Updated
June 27, 2020
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04452123
Brief Title
Endometrioma Treatment and Ovarian Function
Acronym
EnTOF
Official Title
Endometrioma Treatment and Ovarian Function
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioma
Keywords
Endometrioma, AMH
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Argon plasma
Arm Type
Experimental
Arm Description
Patients with endometrioma treated with laparoscopic argon plasma energy.
Arm Title
Stripping and suture/coagulation
Arm Type
Experimental
Arm Description
Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic argon plasma treatment of endometrioma
Intervention Description
Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary
Intervention Description
Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.
Primary Outcome Measure Information:
Title
AMH
Description
Changing of anti-müllerian hormon assay postop. in µg/L
Time Frame
3 days,3-5 week postop., 3 months postop., 1 year (optional)
Title
Antral follicle count (AFC)
Description
Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle
Time Frame
3 months, 1 year
Title
Both ovarian volume
Description
Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle
Time Frame
3 months, 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Humplik, MD
Phone
420377105254
Email
humplikj@fnplzen.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Humplik, MD
Organizational Affiliation
Charles university in Pilsen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of gynecology and obstetrics, University hospital in Pilsen
City
Pilsen
ZIP/Postal Code
30408
Country
Czechia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Humplik, MD
Phone
420377105240
Email
humplikj@fnplzen.cz
12. IPD Sharing Statement
Plan to Share IPD
No
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Endometrioma Treatment and Ovarian Function
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