Subendometrial Injection Versus Intrauterine Infusion of Platelet Rich Plasma for Women With Recurrent Implantation Failure

Subendometrial Injection Versus Intrauterine Infusion of Platelet Rich Plasma for Women With Recurrent Implantation Failure A Prospective Randomized Controlled Study

Aim of this study is to compare the effectiveness of subendometrial PRP injection & intrauterine PRP infusion in women with recurrent implantation failure in comparison with a control group .

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility; Recurrent Implantation Faliure
• Intervention / Treatment: Biological: Platelet rich plasma; Other: No intervention /standard care

Detailed Description

This prospective randomized cotrolled study will be conducted in Private IVF centers in Minia governorate from January 2024 till December 2025,after being approved by the local Ethical committee of the department & written informed consent will be obtained from participants .

All patients will be counselled regarding inclusion in this study ,a written informed consent will be taken from each patient prior to participation in this study.

Recruited patients will be randomly allocated into 3 groups using opaque sealed closed envelops .

Sample size:

Based on previous studies & by using the sample size calculation of GPower software version 3.1.9.6 (Franz Faul, Kiel university, Germany), and setting β at 95% and α at 0.05. This makes sample size of 47 per each group. This figure will be rounded 25. Assuming a drop- out rate of 12%, this will make sample size 60 per each group.

(Group1)-(subendometrial PRP group )SE-PRP(n=60): 4 ml PRP will be injected in this group into the sub endometrial space(1-2 ml)below endometrium at multiple sites trans vaginally & through the cervix after insertion of a cuscow speculum via ovum pick up needle under ultrasound guidance in the luteal phase of previous cycle of FET.

(Group 2)-(intrauterine PRP group )IU-PRP(n=60) Intrauterine infusion of 4 ml PRP will be done during FET cycle when endometrium reaches 7 mm.

(GROUP 3)The control group(n=60) will undergo standard FET with no intervention only hormonal preparation .

Endometrial preparation :

For all groups The Endometrium will be prepared by combined estrogen and progesterone protocol as approved by IVF centeres. Estradiol valerate will be started on day 2/3 of FET cycle at dose of 6mg with measurement of endometrial thickness on the 10 th day of the cycle and every 48 houres & once endometrium is >7mm progesterone vaginal pessary 400 mg twice daily will be offered for luteal support for 3-5 days then embryos of the same number & same quality (grade A top quality embryos ) will be transferred in all patients . Estradiol and progesterone will be continued after the transfer till the 12th week of gestational age if pregnancy occurred.

PRP preparation :

PRP will be prepared from autologous blood using a modified two step centrifuge process. , 8.5 ml of peripheral venous blood will be drawn in the syringe that contained 1.5 ml of Acid Citrate A Anticoagulan solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood will be divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat will be collected to another tube and centrifuged again at 3500 g for 5 min to obtain 1.5 ml PRP with 4-5 times more concentrated .

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 -40 years .
• BMI<30 Kg/m2.
• An IVF procedure resulting in at least one top quality embryo .
• At least one cancelation history of embryo transfer due to thin endometrium (failure of achieving 7 mm endometrial thickness in the cycle) in frozen embryo transfer (FET) cycles after receiving standard hormone therapy.
• Women had a history of failure to achieve pregnancy after two or more embryo transfers with high-quality embryos.

Exclusion Criteria:

• women with other factors that may affect implantation success are excluded: ;

  • BMI >30 kg/m2.
  • Untreated uterine abnormalities.
  • untreated hydrosalpinges.
  • Thrombophilia.
  • uncontrolled endocrinopathy
  • severe male factor infertility.
  • difficult embryo transfer.
  • only poor quality embryos available .
  • couple with chromosomal abnormalities
  • Hematological disorders (blood cancer ,thrombocytopenia )
  • Hormonal disorders (DM,thyroid disorders )
  • Immunological disorders (anti phospholipid syndrome).
  • renal failure
  • Genetic ,chromosomal abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subendometrial PRP group; 4 ml PRP will be injected in this group into the sub endometrial space(1-2 ml)below endometrium at multiple sites trans vaginally & through the cervix after insertion of a cuscow speculum via ovum pick up needle under ultrasound guidance in the luteal phase of previous cycle of FET.	Biological: Platelet rich plasma; Autologous platelet-rich plasma prepared from peripheral blood and administered either by subendometrial injection or intrauterine infusion prior to embryo transfer.
Active Comparator: Intrauterine infusion group; Intrauterine infusion of 4 ml PRP will be done during FET cycle when endometrium reaches 7 mm.	Biological: Platelet rich plasma; Autologous platelet-rich plasma prepared from peripheral blood and administered either by subendometrial injection or intrauterine infusion prior to embryo transfer.
Active Comparator: Control group; will undergo standard FET with no intervention only hormonal preparation .	Other: No intervention /standard care; Participants will receive standard IVF/ICSI care without platelet-rich plasma administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation rate	the ratio of gestational sacs to the number of embryos transferred .	5 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemical pregnancy rate	serum B-hCG 50 IU/L after 14 days from embryo transfer.	14 days after embryo transfer
Clinical pregnancy rate	the presence of a gestational sac with heart beat identified by ultrasound 5 weeks after the embryo transfer.	5 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Platelet Rich Plasma; Recurrent impantation failure
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 1551991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No