EnTOF: Endometrioma Treatment and Ovarian Function

• Sponsor: Charles University, Czech Republic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04452123
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrioma	Procedure: Laparoscopic argon plasma treatment of endometrioma; Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Endometrioma Treatment and Ovarian Function
• Anticipated Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. AMH [3 days,3-5 week postop., 3 months postop., 1 year (optional)]

   Changing of anti-müllerian hormon assay postop. in µg/L

2. Antral follicle count (AFC) [3 months, 1 year]

   Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle

3. Both ovarian volume [3 months, 1 year]

   Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departement of gynecology and obstetrics, University hospital in Pilsen	Pilsen		Czechia	30408

Sponsors and Collaborators

• Charles University, Czech Republic

Investigators

• Principal Investigator: Jan Humplik, MD, Charles university in Pilsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Humplik, MD, Principal investigator, Charles University, Czech Republic
• ClinicalTrials.gov Identifier: NCT04452123
• Other Study ID Numbers: GPKENDO2001
• First Posted: Jun 30, 2020
• Last Update Posted: Jun 30, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jan Humplik, MD, Principal investigator, Charles University, Czech Republic: Endometrioma; AMH
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Jun 30, 2020