Vascular Endothelial Growth Factor Levels at Hysteroscopi... | NCT01735331

Studies
Vascular Endothelial Growth Factor Levels at Hysteroscopic Biopsies Which Taken From Recurrent Pregnancy Loss

NCT01735331

Sponsor

Bagcilar Training and Research Hospital

Status

Completed

Last Update Posted

Aug 7, 2015Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Recurrent Pregnancy Loss Without Current Pregnancy

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 2015

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 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Nov 26, 2012

First Submission Date that Met QC Criteria

Nov 26, 2012

First Posted Date

Nov 28, 2012Estimated

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 6, 2015

Last Update Posted Date

Aug 7, 2015Estimated

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

The aim of this study is determine vascular endothelial growth factor levels and angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels will be measured by immunohistochemical staining methods due to office hysteroscopic endometrial biopsy after the menstruation at follicular phase of menstrual cycle.

Detailed Description

This study is a prospective,observational,single-center study.Ethical approval was obtained from the Institutional Review Board.This study will be completed 30 patients with Habitual Abortus.

Endometrial vascular endothelial growth factor levels will be measured using Flk-1 / Kinase Domain Receptor / Vascular endothelial growth factor receptor-2, Ab-1 (Rabbit PAb), Vascular Endothelial Growth Factor (VEGF) Ab-7 (VG1), Cluster of Differentiation 34 (Endothelial Cell Marker) Ab-1 (QBEnd/10), Vascular endothelial growth factor receptor-1 (N-term) (FLT1) antibody kits. All assays will be performed according to the manufacturer's instructions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VEGF level		VEGF level in hysteroscopic endometrial biopsy of the patients with recurrent pregnancy loss.
control group		Patients with Abnormal Uterine Bleeding

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measure of this study is to determine endometrial vascular endothelial growth factor levels in patient with Recurrent Pregnancy Loss		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Recurrent Pregnancy Loss who accept to join the study.

Exclusion Criteria:

Patients whose age of <18 and >45
Patients with have any pregnancy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

The patients with Recurrent Pregnancy Loss

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
TANER A. USTA, M.D.	Bagcilar Training and Research Hospital,Istanbul,Turkey.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bagcilar Training and Research Hospital		Istanbul			Turkey (Türkiye)