Role of Anti Mullerian Hormone for Ovarian Reserve Determ... | NCT01982526

Studies
Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients

NCT01982526

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Aug 10, 2018Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Endometrioma
Surgery

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Aug 2018

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

May 2012

Primary Completion Date

May 2013Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 6, 2013

First Submission Date that Met QC Criteria

Nov 12, 2013

First Posted Date

Nov 13, 2013Estimated

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

Aug 8, 2018

Last Update Posted Date

Aug 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ergul Demircivi Bor, Medical Doctor, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ovarian reserve influenced by many factor but especially cysts like endometrioma. Anti mullerian hormone is recent marker for ovarian reserve. The investigators are searching ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma patient who are operated for their cysts.

Detailed Description

long term results of the postoperative follow up for the endometrioma patients

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Label	Type	Description	Intervention Names
Endmetrioma surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long term postoperative ovarian reserve outcomes of endometrioma patients by examining antimullerian hormone.		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ultrasonographical symptomatic and benign cysts which has surgery indication.

Exclusion Criteria:

Over 42 years old, systemic endocrine disorder, history of ovarian surgery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

42 Years

Standard Ages

ChildAdult

Study Population

Females who are administring gynecology clinic suffering from symptomatic benign ovarian cysts.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni Sultan Suleyman Education and Research Hospital		Istanbul		34303	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided