Endometriosis
Conditions
Keywords
endometrioma, laparoscopy, ovarian reserve
Brief summary
To compare changes in follicular ovarian reserve in women before and six months after laparoscopic operation: endometrioma stripping surgery. Also, to compare follicular ovarian reserve in women with endometrioma(s) with follicular ovarian reserve of healthy infertile women of the same age group.
Detailed description
In order to investigate the impact of laparoscopic stripping surgery on follicular ovarian reserve, blood samples will be obtained before the operation, from 2nd to 5th day of the menstrual cycle, to determine levels of endocrine markers of ovarian reserve (FSH, E2, AMH and Inhibin B). Cancer antigen 125 (CA -125) and IL-6 will be measured also. US markers (antral follicular count- AFC) will be obtained at the same time as endocrine markers. All laparoscopic stripping surgery will be performed during the early or middle follicular phases of menstrual cycle, under general anesthesia, by the same team of gynecological endoscopist. The cyst wall will be completely stripped off from the normal ovarian tissue by traction and opposite traction with two grasping forceps. Hemostasis will be achieved using bipolar forceps electrocoagulation. All endometrioma specimens that will be obtained from operation will be submitted for pathology examination. One and six months after the laparoscopic cystectomy, from 2nd to 5th day of menstrual cycle, we will determine endocrine markers of ovarian reserve and levels of CA 125 and IL-6. The control group will be consisted of healthy women with infertility problem. From the second to the fifth day of the menstrual cycle we will take blood samples to determinate endocrine markers of follicular ovarian reserve: AMH, FSH, E2, Inhibin B.
Interventions
None listed
Sponsors
Clinical Centre of Serbia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
Study group: Women with endometrioma(s) * Age: 18- 42 years of age * Regular menstrual cycles defined as cycle length between 25- 35 days * Ultrasound made diagnosis of endometrioma unilateral or bilateral ≥4 cm in diameter. * Laparoscopically and histologically confirmed diagnosis. * Agreement to be enrolled in the study Control group: Healthy reproductive aged women with tubal, unexplained or male infertility. \-
Exclusion criteria
* Previous ovarian surgery * Suspicious of malignancy * Known endocrine disorder or other chronic diseases. * Use of oral contraceptive drug, gonadotropin- releasing hormone (GnRH) agonist/ antagonist, or other drugs related with ovarian function in at least 3 months before surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of estradiol (E2) levels | 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy | as the endocrine marker of ovarian reserve |
| Change of Inhibin B levels | 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy | as the endocrine marker of ovarian reserve |
| Change of antral follicular count (AFC) | 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy | as the US marker of ovarian reserve |
| Change of follicle-stimulating hormone (FSH) | 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy | as the endocrine marker of ovarian reserve |
| Change of Anti-mullerian hormone (AMH) levels | 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy | as the endocrine marker of ovarian reserve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of interleukin-6 (IL-6) levels | 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy | as the inflammatory marker |
| Change of CA -125 levels | 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy | as the inflammatory marker |
Countries
Serbia
Contacts
Primary ContactSvetlana S Spremovic- Radjenovic, Professor
Backup ContactNebojsa R Radunovic, Professor
Outcome results
None listed