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Endometrioma Treatment and Ovarian Function

Endometrioma Treatment and Ovarian Function

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04452123
Acronym
EnTOF
Enrollment
100
Registered
2020-06-30
Start date
2020-07-01
Completion date
2023-12-31
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrioma

Keywords

Endometrioma, AMH

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.

Interventions

PROCEDURELaparoscopic argon plasma treatment of endometrioma

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

PROCEDURELaparoscopic 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.

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Both ovarian volume3 months, 1 yearUltrasound volume of both ovaries in cm\^3, measured 3-5. day of menstrual cycle
AMH3 days,3-5 week postop., 3 months postop., 1 year (optional)Changing of anti-müllerian hormon assay postop. in µg/L
Antral follicle count (AFC)3 months, 1 yearUltrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle

Countries

Czechia

Contacts

Primary ContactJan Humplik, MD
humplikj@fnplzen.cz420377105254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026