Clinical trial NCT02047838: Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.
Official title: Impact on Ovarian Reserve of Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas: a Case-control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrioma
Endometriosis
Surgery
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Anti-mullerian hormone (AMH) level.
timeFrame: 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:
measure: Follicle-stimulating hormone (FSH) level.
timeFrame: 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).
measure: 17-beta estradiol level.
timeFrame: 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).
measure: Antral follicle count (AFC).
timeFrame: 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).
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
state: Ligury
Study officials:
affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: Simone Ferrero, PhD
role: STUDY_DIRECTOR
affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: Umberto Leone Roberti Maggiore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrero S, Scala C, Racca A, Calanni L, Remorgida V, Venturini PL, Leone Roberti Maggiore U. Second surgery for recurrent unilateral endometriomas and impact on ovarian reserve: a case-control study. Fertil Steril. 2015 May;103(5):1236-43. doi: 10.1016/j.fertnstert.2015.01.032. Epub 2015 Feb 11.