Skip to main content
OpenTrials
Completed

NCT Number: NCT02047838

Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Surgery Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Genoa, Ligury, 16122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-mullerian hormone (AMH) level dosage.

Other

Follicle-stimulating hormone (FSH) level dosage.

Other

Antral follicle count (AFC).

Other

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2014
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.