Influence of Laparoscopic Endometrioma Stripping Surgery on Serum Anti-mullerian Hormone Levels

• Conditions: Endometriosis

• Registration Number: NCT02286076
• Lead Sponsor: Clinical Centre of Serbia

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.

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-11
• Study First Submitted: 2014-11-01
• Study First Submitted QC: 2014-11-06
• Last Update Submitted: 2014-11-06
• Study First Posted: 2014-11-07
• Last Update Posted: 2014-11-07
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 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 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 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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Department of Laboratory Medicine ''Konzilijum''; 🇷🇸 Belgrade, Serbia

CCSerbia, Clinic for Gynecology and Obstetrics, School of Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia

General Hospital of Subotica; 🇷🇸 Subotica, Vojvodina, Serbia