Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047838
• Other study ID #: Lillo 01/2014
• Status: Completed
• Phase: N/A
• First received: January 25, 2014
• Last updated: November 22, 2014
• Start date: January 2007
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Surgery

Intervention

Other:
• Anti-mullerian hormone (AMH) level dosage.

• Follicle-stimulating hormone (FSH) level dosage.

• Antral follicle count (AFC).

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro	Genoa	Ligury

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No