Endometrioma Treatment and Ovarian Function (EnTOF)

Charles University, Czech Republic

Status: Unknown

Conditions: Endometrioma

Treatments: Procedure: Laparoscopic argon plasma treatment of endometrioma; Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary

Study type: Interventional

Funder types: Other

Identifiers

NCT04452123

GPKENDO2001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Argon plasma

Experimental group

Description:

Patients with endometrioma treated with laparoscopic argon plasma energy.

Treatment:

Procedure: Laparoscopic argon plasma treatment of endometrioma

Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary

Stripping and suture/coagulation

Experimental group

Description:

Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.

Treatment:

Procedure: Laparoscopic argon plasma treatment of endometrioma

Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary