Endometrioma Treatment and Ovarian Function

Not Applicable

• Conditions: Endometrioma
• Interventions: Procedure: Laparoscopic argon plasma treatment of endometrioma; Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary

• Registration Number: NCT04452123
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-27
• Last Update Submitted: 2020-06-27
• Study First Posted: 2020-06-30
• Last Update Posted: 2020-06-30
• Study Start: 2020-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Argon plasma	Laparoscopic argon plasma treatment of endometrioma	Patients with endometrioma treated with laparoscopic argon plasma energy.
Stripping and suture/coagulation	Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary	Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.
Stripping and suture/coagulation	Laparoscopic argon plasma treatment of endometrioma	Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.
Argon plasma	Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary	Patients with endometrioma treated with laparoscopic argon plasma energy.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Departement of gynecology and obstetrics, University hospital in Pilsen; 🇨🇿 Pilsen, Czechia