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Second Laparoscopic Surgery for Recurrent Unilateral Endometriomas.

NCT ID: NCT02047838

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Endometrioma Endometriosis Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cases.

Patients with recurrent unilateral endometrioma who were previously operated for the same condition.

Anti-mullerian hormone (AMH) level dosage.

Intervention Type OTHER

Follicle-stimulating hormone (FSH) level dosage.

Intervention Type OTHER

Antral follicle count (AFC).

Intervention Type OTHER

Controls.

Patients previously operated for unilateral endometrioma without recurrence.

Anti-mullerian hormone (AMH) level dosage.

Intervention Type OTHER

Follicle-stimulating hormone (FSH) level dosage.

Intervention Type OTHER

Antral follicle count (AFC).

Intervention Type OTHER

Interventions

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Anti-mullerian hormone (AMH) level dosage.

Intervention Type OTHER

Follicle-stimulating hormone (FSH) level dosage.

Intervention Type OTHER

Antral follicle count (AFC).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Umberto Leone Roberti Maggiore

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simone Ferrero, PhD

Role: STUDY_DIRECTOR

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

Umberto Leone Roberti Maggiore, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Genoa, Ligury, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 25681854 (View on PubMed)

Other Identifiers

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Lillo 01/2014

Identifier Type: -

Identifier Source: org_study_id