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UnknownNCT02286076

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

Impact of Laparoscopic Endometrioma Stripping Surgery on Fertility: Pre- Operative and Post- Operative Changes of Serum Anti-mullerian Hormone Levels

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Clinical Centre of Serbia · Academic / Other
Sex
Female
Age
18 Years – 42 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2014-05-01
Primary completion
2015-10-01
Completion
2015-12-01
First posted
2014-11-07
Last updated
2014-11-07

Locations

3 sites across 1 country: Serbia

Source: ClinicalTrials.gov record NCT02286076. Inclusion in this directory is not an endorsement.