Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

November 22, 2014 updated by: Umberto Leone Roberti Maggiore, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Impact on Ovarian Reserve of Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas: a Case-control Study.

This retrospective case-control study was performed in an Academic centre for the diagnosis and treatment of endometriosis. It included patients with recurrent unilateral endometriomas who were previously operated for the same condition (cases) and patients without recurrency who previously underwent surgery for unilateral endometrioma (controls). The primary outcome of the study was to assess the impact on ovarian reserve of second surgery for recurrent unilateral endometriomas. The evaluation of ovarian reserve was performed by assessing serum anti-mullerian hormone (AMH) level, serum follicle-stimulating hormone (FSH) level, 17-beta estradiol level and antral follicle count (AFC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Ligury
      • Genoa, Ligury, Italy, 16122
        • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

In this study were recruited women referred to an academic centre for the diagnosis and treatment of endometriosis.

Cases were patients undergoing second surgery for recurrent unilateral endometrioma.

Controls were patients previously operated for unilateral endometrioma.

Description

Inclusion Criteria:

  • reproductive age (at the time of both surgical procedures);
  • two surgical procedures on the same ovary (stripping of endometrioma with
  • largest diameter ≥ 4 cm; cases) performed at our Institution;
  • one surgical procedures (stripping of endometrioma with largest diameter ≥ 4 cm; controls) performed at our Institution;
  • histological diagnosis of ovarian endometriomas;
  • complete assessment of ovarian reserve at routinary follow-up at our institution.

Exclusion Criteria:

  • patients aged ≥ 40 years at the time of primary surgery;
  • surgical procedures on the contralateral ovary (at primary or second-line surgery);
  • previous salpingectomy or hysterectomy;
  • unilateral ovariectomy at the time of first or second surgery;
  • ultrasonographic diagnosis of persistent endometrioma after first surgery;
  • additional surgical procedures for endometriomas or for other ovarian diseases before first surgery and between first and second surgery;
  • hormonal treatment within 3 months from ovarian reserve assessment;
  • patients followed-up < 3 months after second-line surgery (for cases).
  • pregnancy and/or breastfeeding during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases.
Patients with recurrent unilateral endometrioma who were previously operated for the same condition.
Other: Anti-mullerian hormone (AMH) level dosage.
Other: Follicle-stimulating hormone (FSH) level dosage.
Other: Antral follicle count (AFC).
Controls.
Patients previously operated for unilateral endometrioma without recurrence.
Other: Anti-mullerian hormone (AMH) level dosage.
Other: Follicle-stimulating hormone (FSH) level dosage.
Other: Antral follicle count (AFC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-mullerian hormone (AMH) level.
Time Frame: In cases, anti-mullerian hormone (AMH) level was determined 3 months after second laparoscopic surgery. In controls, AMH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
In cases, anti-mullerian hormone (AMH) level was determined 3 months after second laparoscopic surgery. In controls, AMH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).

Secondary Outcome Measures

Outcome Measure
Time Frame
Follicle-stimulating hormone (FSH) level.
Time Frame: In cases, follicle-stimulating hormone (FSH) level was determined 3 months after second laparoscopic surgery. In controls, FSH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
In cases, follicle-stimulating hormone (FSH) level was determined 3 months after second laparoscopic surgery. In controls, FSH levels was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
17-beta estradiol level.
Time Frame: In cases, 17-beta estradiol level was determined 3 months after second laparoscopic surgery. In controls, 17-beta estradiol level was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
In cases, 17-beta estradiol level was determined 3 months after second laparoscopic surgery. In controls, 17-beta estradiol level was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
Antral follicle count (AFC).
Time Frame: In cases, antral follicle count (AFC) was determined 3 months after second laparoscopic surgery. In controls, antral follicle count was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).
In cases, antral follicle count (AFC) was determined 3 months after second laparoscopic surgery. In controls, antral follicle count was determined in the the fertility assessment performed during follow-up (matched to the correspondent case).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

January 25, 2014

First Submitted That Met QC Criteria

January 25, 2014

First Posted (ESTIMATE)

January 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 22, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lillo 01/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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