Clinical trial NCT02286076: Influence of Laparoscopic Endometrioma Stripping Surgery on Serum Anti-mullerian Hormone Levels
Official title: Impact of Laparoscopic Endometrioma Stripping Surgery on Fertility: Pre- Operative and Post- Operative Changes of Serum Anti-mullerian Hormone Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: endometrioma
laparoscopy
ovarian reserve
Lead sponsor: Clinical Centre of Serbia
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: study group: patients with diagnosed endometrioma(s) in one ovary or in both ovaries, in reproductive years, otherwise healthy

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.

Eligibility criteria: 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.

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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.

Primary outcomes:
measure: Change of follicle-stimulating hormone (FSH)
timeFrame: 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
measure: Change of estradiol (E2) levels
timeFrame: 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
measure: Change of Anti-mullerian hormone (AMH) levels
timeFrame: 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
measure: Change of Inhibin B levels
timeFrame: 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
measure: Change of antral follicular count (AFC)
timeFrame: 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
Secondary outcomes:
measure: Change of CA -125 levels
timeFrame: 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
measure: Change of interleukin-6 (IL-6) levels
timeFrame: 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
Other outcomes:
Locations:
city: Subotica
country: Serbia
facility: General Hospital of Subotica
state: Vojvodina
city: Belgrade
country: Serbia
facility: CCSerbia, Clinic for Gynecology and Obstetrics, School of Medicine, University of Belgrade
city: Belgrade
country: Serbia
facility: Department of Laboratory Medicine ''Konzilijum''
Study officials:
affiliation: CCSerbia, School of Medicine, University of Belgrade
name: Svetlana S Spremovic-Radjenovic, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Kitajima M, Defrere 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.
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.
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.
citation: Somigliana E, Berlanda N, Benaglia L, Vigano P, Vercellini P, Fedele L. Surgical excision of endometriomas and ovarian reserve: a systematic review on serum antimullerian hormone level modifications. Fertil Steril. 2012 Dec;98(6):1531-8. doi: 10.1016/j.fertnstert.2012.08.009. Epub 2012 Sep 10.
citation: 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.