Viewing Study NCT04452123



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Last Modification Date: 2024-10-26 @ 1:39 PM
Study NCT ID: NCT04452123
Status: UNKNOWN
Last Update Posted: 2020-06-30
First Post: 2020-06-12

Brief Title: Endometrioma Treatment and Ovarian Function
Sponsor: Charles University Czech Republic
Organization: Charles University Czech Republic

Study Overview

Official Title: Endometrioma Treatment and Ovarian Function
Status: UNKNOWN
Status Verified Date: 2020-06
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EnTOF
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 womans 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None