Endometrioma Treatment and Ovarian Function

Study Overview
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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.

Official Title
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Endometrioma Treatment and Ovarian Function

Conditions
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Endometrioma

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Argon plasma<br>Patients with endometrioma treated with laparoscopic argon plasma energy. | Procedure: Laparoscopic argon plasma treatment of endometrioma<br>* Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible<br>Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary<br>* Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.<br>|
| Experimental: Stripping and suture/coagulation<br>Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary. | Procedure: Laparoscopic argon plasma treatment of endometrioma<br>* Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible<br>Procedure: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary<br>* Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMH, Endometrioma