PRP Intrauterine Infusion in Thawed Embryo Cycles

Intrauterine Infusion of Platelet-rich Plasma Infusion Before Thawed Embryo Transfer in Repeated Implantation Failure: A Randomized Controlled Study

All patients prepared to thawed embryo transfer were classified into 2 groups one group will receive platelet rich plasma (PRP) infusion intrauterine and the other group will not receive platelet rich plasma (PRP) infusion

Study Overview

• Status: Completed
• Conditions: Evaluations
• Intervention / Treatment: Biological: Platelet rich plasma intrauterine infusion; Biological: Normal saline

Detailed Description

Patients candidates for Thawed embryo transfer with Repeated implantation failure were recruited from 3 centers and classified into 2 groups:

Group I: Will receive platelet rich plasma (PRP) intrauterine infusion at day 11

Group II: Not receiving platelet rich plasma (PRP)

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Ayman Shehata Dawood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients age 20-35 years
• Patients with previous implantation failure
• Patients with thin endometrium<7 mm

Exclusion Criteria:

• Patients older than 40 years
• Patients with fresh embryo transfer
• Patients with abnormal uterine cavity septate, or bicornuate uterus
• Patients with abnormal male factor or tubal factor
• Patients with abnormal embryos grade B or C.
• Patients with immunological disorders as thyroidits or systemic lupus or rheumatoid arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP group; These patients will receive platelet rich plasma intrauterine infusion at day 11	Biological: Platelet rich plasma intrauterine infusion; platelet rich plasma will be prepared, activated then infused by Intrauterine insemination catheter intrauterine at day 11
Placebo Comparator: Control group; These patients will receive intrauterine normal saline infusion at day 11	Biological: Normal saline; Intrauterine infusion of normal saline at day 11

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial thickness	The increase in endometrial thickness at day of ET	8 days
Pregnancy rate	Number of cases who got pregnant	15 days

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Platelet rich plasma; Intrauterine infusion; Thawed embryos; IVF/ICSI cycles
• Other Study ID Numbers: PRPF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not allowed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No