Endometrioma Treatment and Ovarian Function

NCT ID: NCT04452123

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Endometrioma

Keywords

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Endometrioma AMH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Argon plasma

Patients with endometrioma treated with laparoscopic argon plasma energy.

Group Type EXPERIMENTAL

Laparoscopic argon plasma treatment of endometrioma

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.

Stripping and suture/coagulation

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

Group Type EXPERIMENTAL

Laparoscopic argon plasma treatment of endometrioma

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.

Interventions

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Laparoscopic argon plasma treatment of endometrioma

Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Jan Humplik, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Humplik, MD

Role: PRINCIPAL_INVESTIGATOR

Charles university in Pilsen

Locations

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Departement of gynecology and obstetrics, University hospital in Pilsen

Pilsen, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Jan Humplik, MD

Role: CONTACT

Phone: 420377105254

Email: [email protected]

Facility Contacts

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Jan Humplik, MD

Role: primary

Other Identifiers

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GPKENDO2001

Identifier Type: -

Identifier Source: org_study_id