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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02286076
• Other study ID #: 1040/30
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2014
• Last updated: November 6, 2014
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Clinical Centre of Serbia
• Contact: Svetlana S Spremovic- Radjenovic, Professor
• Phone: 63696246
• Email: spremovics[@]gmail.com
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Serbia	CCSerbia, Clinic for Gynecology and Obstetrics, School of Medicine, University of Belgrade	Belgrade
Serbia	Department of Laboratory Medicine ``Konzilijum``	Belgrade
Serbia	General Hospital of Subotica	Subotica	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Centre of Serbia

Country where clinical trial is conducted

Serbia, 

References & Publications (6)

Hart RJ, Hickey M, Maouris P, Buckett W. Excisional surgery versus ablative surgery for ovarian endometriomata. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004992. doi: 10.1002/14651858.CD004992.pub3. Review. — View Citation

Jadoul P, Kitajima M, Donnez O, Squifflet J, Donnez J. Surgical treatment of ovarian endometriomas: state of the art? Fertil Steril. 2012 Sep;98(3):556-63. doi: 10.1016/j.fertnstert.2012.06.023. Epub 2012 Jul 3. Review. — View Citation

Kitajima M, Defrère S, Dolmans MM, Colette S, Squifflet J, Van Langendonckt A, Donnez J. Endometriomas as a possible cause of reduced ovarian reserve in women with endometriosis. Fertil Steril. 2011 Sep;96(3):685-91. doi: 10.1016/j.fertnstert.2011.06.064. Epub 2011 Jul 29. — View Citation

Muzii L, Di Tucci C, Di Feliciantonio M, Marchetti C, Perniola G, Panici PB. The effect of surgery for endometrioma on ovarian reserve evaluated by antral follicle count: a systematic review and meta-analysis. Hum Reprod. 2014 Oct 10;29(10):2190-8. doi: 10.1093/humrep/deu199. Epub 2014 Aug 1. Review. — View Citation

Raffi F, Metwally M, Amer S. The impact of excision of ovarian endometrioma on ovarian reserve: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2012 Sep;97(9):3146-54. doi: 10.1210/jc.2012-1558. Epub 2012 Jun 20. Review. — View Citation

Somigliana E, Berlanda N, Benaglia L, Viganò P, Vercellini P, Fedele L. Surgical excision of endometriomas and ovarian reserve: a systematic review on serum antimüllerian hormone level modifications. Fertil Steril. 2012 Dec;98(6):1531-8. doi: 10.1016/j.fertnstert.2012.08.009. Epub 2012 Sep 10. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of follicle-stimulating hormone (FSH)	as the endocrine marker of ovarian reserve	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	Yes
Primary	Change of estradiol (E2) levels	as the endocrine marker of ovarian reserve	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	Yes
Primary	Change of Anti-mullerian hormone (AMH) levels	as the endocrine marker of ovarian reserve	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	Yes
Primary	Change of Inhibin B levels	as the endocrine marker of ovarian reserve	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	Yes
Primary	Change of antral follicular count (AFC)	as the US marker of ovarian reserve	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	Yes
Secondary	Change of CA -125 levels	as the inflammatory marker	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	Yes
Secondary	Change of interleukin-6 (IL-6) levels	as the inflammatory marker	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	Yes