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EndometriosisNCT02286076

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

An observational study of Endometriosis, run by Clinical Centre of Serbia at 3 sites in Serbia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 42 years, women only
Conditions the study is for
Endometriosis
How many people
100 participants
Where
3 sitesSerbia
Study dates
May 2014to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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.
  • -

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Svetlana S Spremovic- Radjenovic, Professor contact

63696246 ext. +381

spremovics@gmail.com

Nebojsa R Radunovic, Professor contact

63200204 ext. +381

radunn01@gmail.com

Serbia3 sites, 3 recruiting

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

    Belgrade, 11000

    Svetlana S Spremovic- Radjenovic, Professor, 63696246 ext. +381, spremovics@gmail.com

    Nebojsa R Radunovic, Professor, 63200204 ext. +381, radunn01@gmail.com

    Recruiting

  • Department of Laboratory Medicine ''Konzilijum''

    Belgrade, 11000

    Drina S Topalov, Pharmacist, 63555866 ext. +381, drina.topalov@gmail.com

    Recruiting

  • General Hospital of Subotica

    Subotica, Vojvodina, 24000

    Luka M Andjelic, Gyn&Obstet, 63508812 ext. +381, lukaandjelic52@gmail.com

    Vera M Kovacevic, Gyn&Obstet, 695713573 ext. +381, veramkov@gmail.com

    Recruiting

Other trials in Serbia

About this study

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

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.

Read the 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.

Conditions
Endometriosis
Keywords
endometrioma, laparoscopy, ovarian reserve
Medical subject headings
Endometriosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of follicle-stimulating hormone (FSH)

    as the endocrine marker of ovarian reserve

    Measured: 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

  2. Change of estradiol (E2) levels

    as the endocrine marker of ovarian reserve

    Measured: 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

  3. Change of Anti-mullerian hormone (AMH) levels

    as the endocrine marker of ovarian reserve

    Measured: 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

  4. Change of Inhibin B levels

    as the endocrine marker of ovarian reserve

    Measured: 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

  5. Change of antral follicular count (AFC)

    as the US marker of ovarian reserve

    Measured: 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)

  1. Change of CA -125 levels

    as the inflammatory marker

    Measured: 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

  2. Change of interleukin-6 (IL-6) levels

    as the inflammatory marker

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionOct 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02286076
Sponsor's protocol ID
1040/30
Status last verified
Nov 2014
First submitted
1 Nov 2014
Last updated
7 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22763094

  • 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.

    PubMed 21802672

  • 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.

    PubMed 25085800

  • 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.

    PubMed 22723324

  • 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.

    PubMed 22975114

  • 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.

    PubMed 18425908

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by Clinical Centre of Serbia at 3 sites in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Svetlana S Spremovic- Radjenovic, Professor (63696246 ext. +381, spremovics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of follicle-stimulating hormone (FSH) (time frame: 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02286076, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2014.

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