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

NCT ID: NCT02286076

Last Updated: 2014-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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

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Endometriosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinical Centre of Serbia

OTHER

Sponsor Role lead

Responsible Party

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Svetlana Spremovic- Radjenovic

Professor of Gynecology and Obstetrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Svetlana S Spremovic-Radjenovic, Professor

Role: PRINCIPAL_INVESTIGATOR

CCSerbia, School of Medicine, University of Belgrade

Locations

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General Hospital of Subotica

Subotica, Vojvodina, Serbia

Site Status RECRUITING

CCSerbia, Clinic for Gynecology and Obstetrics, School of Medicine, University of Belgrade

Belgrade, , Serbia

Site Status RECRUITING

Department of Laboratory Medicine ''Konzilijum''

Belgrade, , Serbia

Site Status RECRUITING

Countries

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Serbia

Central Contacts

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Svetlana S Spremovic- Radjenovic, Professor

Role: CONTACT

[email protected]
63696246 ext. +381

Nebojsa R Radunovic, Professor

Role: CONTACT

[email protected]
63200204 ext. +381

Facility Contacts

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Luka M Andjelic, Gyn&Obstet

Role: primary

[email protected]
63508812 ext. +381

Vera M Kovacevic, Gyn&Obstet

Role: backup

[email protected]
695713573 ext. +381

Svetlana S Spremovic- Radjenovic, Professor

Role: primary

[email protected]
63696246 ext. +381

Nebojsa R Radunovic, Professor

Role: backup

[email protected]
63200204 ext. +381

Drina S Topalov, Pharmacist

Role: primary

[email protected]
63555866 ext. +381

References

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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.

Reference Type BACKGROUND
PMID: 22763094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21802672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25085800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22723324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22975114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18425908 (View on PubMed)

Other Identifiers

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1040/30

Identifier Type: -

Identifier Source: org_study_id