NCT02286076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

1.4 years

First QC Date

November 1, 2014

Last Update Submit

November 6, 2014

Conditions

Endometriosis

Keywords

endometriomalaparoscopyovarian reserve

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (2)

  • Change of CA -125 levels

    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

    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

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

study group: patients with diagnosed endometrioma(s) in one ovary or in both ovaries, in reproductive years, otherwise healthy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

General Hospital of Subotica

Subotica, Vojvodina, 24000, Serbia

RECRUITING

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

Belgrade, 11000, Serbia

RECRUITING

Department of Laboratory Medicine ''Konzilijum''

Belgrade, 11000, Serbia

RECRUITING

Related Publications (6)

  • 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.

    PMID: 22763094BACKGROUND

  • 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.

    PMID: 21802672BACKGROUND

  • 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.

    PMID: 25085800BACKGROUND

  • 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.

    PMID: 22723324BACKGROUND

  • 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.

    PMID: 22975114BACKGROUND

  • 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.

    PMID: 18425908BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The endometrioma specimens that will be obtained from operation will be submitted for pathology examination

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Svetlana S Spremovic-Radjenovic, Professor

    CCSerbia, School of Medicine, University of Belgrade

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Svetlana S Spremovic- Radjenovic, Professor

CONTACT

63696246spremovics@gmail.com

Nebojsa R Radunovic, Professor

CONTACT

63200204radunn01@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Gynecology and Obstetrics

Study Record Dates

First Submitted

November 1, 2014

First Posted

November 7, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations

SE(3)