The Effect of Surgery for Non Endometriosic Ovarian Cysts... | NCT02852447

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

NCT02852447

Sponsor

Corporacion Parc Tauli

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Antimullerian Hormone
Ovarian Cysts
Antral Follicle Count

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Oct 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jul 1, 2016

First Submission Date that Met QC Criteria

Jul 28, 2016

First Posted Date

Aug 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2017

Last Update Posted Date

Feb 23, 2017Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Ovarian Size (mm)		3 months
Time of surgery (minutes)		3 months
Age (years)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Patients with bening ovarian cyst and requiring surgical removal

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Corporació Sanitària Parc Tauli		Sabadell	Barcelona	08208	Spain

Condition Browse Module

MeSH Terms

ID	Term
D010048	Ovarian Cysts

Ancestor Terms

ID	Term
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided