Platelet-Rich Protein and the Endometrium | NCT02973555

Studies
Platelet-Rich Protein and the Endometrium

NCT02973555

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Nov 25, 2016Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

PRP injection

Countries

Israel

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

Nov 2016

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

Jan 2017

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Nov 22, 2016

First Submission Date that Met QC Criteria

Nov 22, 2016

First Posted Date

Nov 25, 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

Nov 22, 2016

Last Update Posted Date

Nov 25, 2016Estimated

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

Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome of patients with thin endometrium undergoing ART treatments.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRP injection	Experimental		Other: PRP injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRP injection	Other	autologous intrauterine infusion of PRP	PRP injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endometrial thickness >7mm		1 month

Secondary Outcomes

Measure	Description	Time Frame
Positive serum pregnancy test		14 days post embryo transfer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women undergoing a frozen thawed embryo transfer cycle with poor endometrial response to estrogen (< 7 mm) after at least two standard preparation protocols, of which one was canceled due to thin endometrium

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

54 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ronit Kochman, MD	Contact	+972 508946414		kochman@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Ronit Kochman, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel

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
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided