NCT02047838

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

6.9 years

First QC Date

January 25, 2014

Last Update Submit

November 22, 2014

Conditions

EndometriomaEndometriosisSurgery

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • 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).

  • 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).

  • 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).

Study Arms (2)

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).

Interventions

Anti-mullerian hormone (AMH) level dosage.OTHER
Cases.Controls.
Follicle-stimulating hormone (FSH) level dosage.OTHER
Cases.Controls.
Antral follicle count (AFC).OTHER
Cases.Controls.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Genoa, Ligury, 16122, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25681854DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Anti-Mullerian HormoneFollicle Stimulating Hormone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Testicular HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsGonadotropins, PituitaryGonadotropinsPeptide HormonesPituitary Hormones, AnteriorPituitary HormonesPeptides

Study Officials

  • Simone Ferrero, PhD

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

    STUDY DIRECTOR

  • Umberto Leone Roberti Maggiore, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 25, 2014

First Posted

January 28, 2014

Study Start

January 1, 2007

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

IT(1)