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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change of interleukin-6 (IL-6) levels |
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Inclusion Criteria:Study group: Women with endometrioma(s)
Control group: Healthy reproductive aged women with tubal, unexplained or male infertility.
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Exclusion Criteria:
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study group: patients with diagnosed endometrioma(s) in one ovary or in both ovaries, in reproductive years, otherwise healthy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Svetlana S Spremovic- Radjenovic, Professor | Contact | 63696246 | +381 | spremovics@gmail.com |
| Nebojsa R Radunovic, Professor | Contact | 63200204 | +381 | radunn01@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Svetlana S Spremovic-Radjenovic, Professor | CCSerbia, School of Medicine, University of Belgrade | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Subotica | Recruiting | Subotica | Vojvodina | 24000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22763094 | Background | 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. | |
| 21802672 | Background | 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. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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The endometrioma specimens that will be obtained from operation will be submitted for pathology examination
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 |
| CCSerbia, Clinic for Gynecology and Obstetrics, School of Medicine, University of Belgrade | Recruiting | Belgrade | 11000 | Serbia |
|
| Department of Laboratory Medicine ''Konzilijum'' | Recruiting | Belgrade | 11000 | Serbia |
|
| 25085800 | Background | 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. |
| 22723324 | Background | 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. |
| 22975114 | Background | 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. |
| 18425908 | Background | 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. |
| D000091662 | Genital Diseases |