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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852447
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Laura Costa-Canals, Corporacion Parc Tauli

Brief Summary:

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


Condition or disease
Antimullerian Hormone Ovarian Cysts Antral Follicle Count

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve : A Prospective Study
Study Start Date : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts




Primary Outcome Measures :
  1. differences in the ovarian reserve before and after surgery by Antimullerian Hormone [ Time Frame: 3 months ]
  2. differences in the ovarian reserve before and after surgery by Antral Follicle Count [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Ovarian Size (mm) [ Time Frame: 3 months ]
  2. Time of surgery (minutes) [ Time Frame: 3 months ]
  3. Age (years) [ Time Frame: 3 months ]
  4. BMI in kg/m2 [ Time Frame: 3 months ]

Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with bening ovarian cyst and requiring surgical removal
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852447


Locations
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Spain
Corporació Sanitària Parc Tauli
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
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Responsible Party: Laura Costa-Canals, MD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02852447    
Other Study ID Numbers: CPT-GINE-2016
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Cysts
Ovarian Cysts
Neoplasms
Pathological Conditions, Anatomical
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases