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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02852447
Other study ID # CPT-GINE-2016
Secondary ID
Status Completed
Phase N/A
First received July 1, 2016
Last updated February 22, 2017
Start date November 2014
Est. completion date December 2016

Study information

Verified date February 2017
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 40 Years
Eligibility 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 Design


Locations

Country Name City State
Spain Corporació Sanitària Parc Tauli Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary differences in the ovarian reserve before and after surgery by Antimullerian Hormone 3 months
Primary differences in the ovarian reserve before and after surgery by Antral Follicle Count 3 months
Secondary Ovarian Size (mm) 3 months
Secondary Time of surgery (minutes) 3 months
Secondary Age (years) 3 months
Secondary BMI in kg/m2 3 months
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