Endometrioma Treatment and Ovarian Function

Endometrioma Clinical Trial

— EnTOF  

Official title:

Endometrioma Treatment and Ovarian Function

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04452123
• Other study ID #: GPKENDO2001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2020
• Source: Charles University, Czech Republic
• Contact: Jan Humplik, MD
• Phone: 420377105254
• Email: humplikj[@]fnplzen.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

Intervention

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
• 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.

Locations

Country	Name	City	State
Czechia	Departement of gynecology and obstetrics, University hospital in Pilsen	Pilsen

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMH	Changing of anti-müllerian hormon assay postop. in µg/L	3 days,3-5 week postop., 3 months postop., 1 year (optional)
Primary	Antral follicle count (AFC)	Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle	3 months, 1 year
Primary	Both ovarian volume	Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle	3 months, 1 year