Use of Platelet Rich Plasma (PRP) for Improving Thin Endometrium (PRPITM)

July 11, 2018 updated by: Muhammad Fawzy, Ibn Sina Hospital

Use of Platelet Rich Plasma (PRP) for Improving Thin Endometrium For IVF Women

Platelets rich plasma is simple source of growth factors and cytokines that can regulate endometrial growth for subgroup of thin endometrium women. It is an autologous source of this enhancing factors; therefore, there os no risk of using it within the same participant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12345
        • Gannah IVF unit, Gannah Hospital
      • Sohag, Egypt, 12345
        • IbnSina IVF Center, IbnSina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with thin endometrium

Exclusion Criteria:

  • serum positive hepatitis B and C women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PRP injection into Uterine Cavity
PRP injection into Uterine Cavity For Treatment of Thin Endometrium
Other: Treatment of Thin Endometrium
This is a trial to improve endometrial thickness by autologous injection of PRP into the Uterine Cavity compared with CSF or no treatment.
EXPERIMENTAL: CSF (colony stimulating factor)
CSF for Treatment of Thin Endometrium
Other: Treatment of Thin Endometrium
This is a trial to improve endometrial thickness by autologous injection of PRP into the Uterine Cavity compared with CSF or no treatment.
NO_INTERVENTION: No intervention
The control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Diameter of endometrial thickness
Time Frame: 2 days
How the endometrium would respond after 2 days of PRP
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 4 weeks or beyond after embryo Transfer
Registered fetal heartbeat 4 weeks or beyond after embryo transfer.
4 weeks or beyond after embryo Transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibn Sina Hospital

Collaborators

Ganna Hospital

Investigators

  • Principal Investigator: Ayman S El-Gohary, MD, Ganna Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2017

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Ibnsina-Ganna-PRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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