Endometrioma Treatment and Ovarian Function (EnTOF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endometrioma
• Intervention / Treatment: Procedure: Laparoscopic argon plasma treatment of endometrioma; Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Humplik, MD; Phone Number: 420377105254; Email: humplikj@fnplzen.cz

Study Locations

• Czechia
  • Pilsen, Czechia, 30408
    • Departement of gynecology and obstetrics, University hospital in Pilsen
    • Contact: Jan Humplik, MD; Phone Number: 420377105240; Email: humplikj@fnplzen.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Jan Humplik, MD, Charles university in Pilsen

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 27, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 27, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: AMH; Endometrioma
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: GPKENDO2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No