Endometrioma Treatment and Ovarian Function

NCT04452123 | Unknown

• 1 other identifier: GPKENDO2001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrioma

Keywords

Endometrioma; AMH

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Argon plasma

EXPERIMENTAL

Patients with endometrioma treated with laparoscopic argon plasma energy.

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

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

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

Interventions

Laparoscopic argon plasma treatment of endometrioma PROCEDURE

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

Argon plasma; Stripping and suture/coagulation

Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary PROCEDURE

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

Argon plasma; Stripping and suture/coagulation

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women with endometrioma 3cm and more in diameter

You may not qualify if:

• using hormonal contraception or other hormonal treatment last 6 months
• suffer with polycystic ovarian syndrome

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Departement of gynecology and obstetrics, University hospital in Pilsen

Pilsen, 30408, Czechia

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Sutures

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Jan Humplik, MD

  Charles university in Pilsen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Humplik, MD

CONTACT

420377105254; humplikj@fnplzen.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 30, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)