Serum Ghrelin in Polycystic Ovary Syndrome | NCT02087410

Studies
Serum Ghrelin in Polycystic Ovary Syndrome

NCT02087410

Sponsor

amr hesham el etreby

Status

Unknown status

Last Update Posted

Mar 14, 2014Estimated

Enrollment

84Estimated

Phase

Not provided

Conditions

Polycystic Ovary

Interventions

Not provided

Countries

Egypt

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Oct 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Mar 12, 2014

First Submission Date that Met QC Criteria

Mar 13, 2014

First Posted Date

Mar 14, 2014Estimated

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

Mar 13, 2014

Last Update Posted Date

Mar 14, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

amr hesham el etreby, resident maternity hospital, Ain Shams UniversitySponsor-Investigator

Lead Sponsor

amr hesham el etrebyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy levels

Detailed Description

two groups one healthy and other with pco measure ghrelin level in both of them to find relation between pco and ghrelin

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

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study		patients with polycystic ovary syndrome
control		healthy patients serves as control group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
relationships between circulating ghrelin and the clinical and biochemical manifestations of PCOS	Analysis of levels of ghrelin in study group	after 6 monthes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:pco women

At least 12 months of infertility.
Patients with polycystic ovarian syndrome according to Rotterdam criteria:

Exclusion Criteria:

Patients with hyperprolactinemia
Patients with Cushing's syndrome
Patients with Congenital or non-classical adrenal hyperplasia
Patients with hormone secreting tumors.
Patients with hormonal treatment in the last 3 months.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Forty two patients with polycystic ovarian syndrome and forty two healthy subjects will be recruited from the outpatient clinic Ain Shams University Maternity Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
amr eletrby, MBBCH	ain shams universty maternity hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternity Hospital		Cairo	Cairo Governorate		Egypt

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided