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Platelet-Rich Protein and the Endometrium

Primary Purpose

Infertility

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

PRP injection

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 54 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hadassah Medical Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP injection

Arm Description

Outcomes

Primary Outcome Measures

endometrial thickness >7mm

Secondary Outcome Measures

Positive serum pregnancy test

Full Information

NCT ID

NCT02973555

First Posted

November 22, 2016

Last Updated

November 22, 2016

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT02973555

Brief Title

Platelet-Rich Protein and the Endometrium

Official Title

Can Platelet-rich Plasma (PRP) Promote Endometrial Growth and Improve Pregnancy Outcome of Patients With Thin Endometrium Undergoing Assisted Reproductive Technology (ART) Treatments?

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRP injection

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

PRP injection

Intervention Description

autologous intrauterine infusion of PRP

Primary Outcome Measure Information:

Title

endometrial thickness >7mm

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Positive serum pregnancy test

Time Frame

14 days post embryo transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

54 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronit Kochman, MD

Phone

+972 508946414

kochman@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronit Kochman, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Platelet-Rich Protein and the Endometrium

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