Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy (Other)
Overall Status
Completed
CT.gov ID
NCT02047838
Collaborator
(none)
36
1
83
0.4

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Anti-mullerian hormone (AMH) level dosage.
  • Other: Follicle-stimulating hormone (FSH) level dosage.
  • Other: Antral follicle count (AFC).

Study Design

Study Type:
Observational
Actual Enrollment :
36 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Impact on Ovarian Reserve of Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas: a Case-control Study.
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Anti-mullerian hormone (AMH) level. [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

  1. Follicle-stimulating hormone (FSH) level. [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).]

  2. 17-beta estradiol level. [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).]

  3. Antral follicle count (AFC). [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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genoa Ligury Italy 16122

Sponsors and Collaborators

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

Investigators

  • Study Director: Simone Ferrero, PhD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  • Principal Investigator: Umberto Leone Roberti Maggiore, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Umberto Leone Roberti Maggiore, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT02047838
Other Study ID Numbers:
  • Lillo 01/2014
First Posted:
Jan 28, 2014
Last Update Posted:
Nov 25, 2014
Last Verified:
Nov 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2014