The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve

February 22, 2017 updated by: Laura Costa-Canals, Corporacion Parc Tauli

The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve : A Prospective Study

The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.

The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with bening ovarian cyst and requiring surgical removal

Description

Inclusion Criteria:

  • Patients with non endometriosis ovarian cysts
  • Age between 15-40 years
  • Regulars menses
  • Signed informed consent

Exclusion Criteria:

  • Patients with Previous surgery,
  • Patients with infertility,
  • Patients with endometriosis or
  • Patients with suspicious of malignance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
differences in the ovarian reserve before and after surgery by Antimullerian Hormone
Time Frame: 3 months
3 months
differences in the ovarian reserve before and after surgery by Antral Follicle Count
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ovarian Size (mm)
Time Frame: 3 months
3 months
Time of surgery (minutes)
Time Frame: 3 months
3 months
Age (years)
Time Frame: 3 months
3 months
BMI in kg/m2
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 1, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPT-GINE-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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