NCT02660294

Brief Summary

Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

January 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

January 16, 2016

Last Update Submit

March 19, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • endometrial thickness in mm

    using transvaginal ultrasound to measure endometrial thickness in mm

    72 hours

Secondary Outcomes (1)

  • clinical pregnancy rate

    4 weeks after embryo transfer

Study Arms (2)

Platlet rich plasma

EXPERIMENTAL

For those with endometrial thickness less than 7 mm intrauterine injection of platlet rich plasma (PRP) for enhancing endometrial thickness and receptivity

Biological: platlet rich plasma

Hormone replacement therapy

NO INTERVENTION

Oral intake of estradiol valerate for those with endometrial thickness less than 7 mm will improve endometrial receptivity

Interventions

platlet rich plasmaBIOLOGICAL

Platelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood

Platlet rich plasma

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients undergoing ICSI
  • endometrial thickness less than 7 mm on early follicular phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rasha

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • RASHA DR MEDHAT, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

rasha Dr medhat, MD

CONTACT

1224448449RASHAMEDHAT30@GMAIL.COM

ahmed DR kotb, MD

CONTACT

1008681999ahmedmkotp@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR. Rasha Medhat Abdul-hady

Study Record Dates

First Submitted

January 16, 2016

First Posted

January 21, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

EG(1)