NCT03166345

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

May 18, 2017

Last Update Submit

July 11, 2018

Conditions

Poor Endometrium

Outcome Measures

Primary Outcomes (1)

  • Mean Diameter of endometrial thickness

    How the endometrium would respond after 2 days of PRP

    2 days

Secondary Outcomes (1)

  • Clinical pregnancy rate

    4 weeks or beyond after embryo Transfer

Study Arms (3)

PRP injection into Uterine Cavity

EXPERIMENTAL

PRP injection into Uterine Cavity For Treatment of Thin Endometrium

Other: Treatment of Thin Endometrium

CSF (colony stimulating factor)

EXPERIMENTAL

CSF for Treatment of Thin Endometrium

Other: Treatment of Thin Endometrium

No intervention

NO INTERVENTION

The control arm.

Interventions

Treatment of Thin EndometriumOTHER

This is a trial to improve endometrial thickness by autologous injection of PRP into the Uterine Cavity compared with CSF or no treatment.

CSF (colony stimulating factor)PRP injection into Uterine Cavity

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with thin endometrium

You may not qualify if:

  • serum positive hepatitis B and C women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gannah IVF unit, Gannah Hospital

Giza, 12345, Egypt

Location

IbnSina IVF Center, IbnSina Hospital

Sohag, 12345, Egypt

Location

Study Officials

  • Ayman S El-Gohary, MD

    Ganna Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 25, 2017

Study Start

August 15, 2017

Primary Completion

March 30, 2018

Study Completion

April 1, 2018

Last Updated

July 12, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)