PRP in Recurrent Implantation Failure

PRP in Recurrent Implantation Failure , Hope or Hype

The endometrial function and endometrial receptivity have been accepted to be major limiting factors in the establishment of pregnancy. In spite of improved almost all aspects of IVF: ovarian stimulation, embryo culture and transfer, the pregnancy rates still not satisfactory. The bottleneck is the process of implantation.

Recurrent implantation failure (RIF) is one of the nightmares in reproductive medicine and despite several strategies that have been described for management; there is no universal agreement yet.

Recently, intrauterine infusion of platelet-rich plasma (PRP) is described to promote endometrial growth and receptivity, PRP has been investigated as a therapeutic approach for several medical disorders in dermatology and rheumatology, but its use in IVF is still limited.

Objective:

To evaluate the effectiveness of intrauterine perfusion of autologous platelet-rich plasma in the improvement of pregnancy rate in RIF patients.

Study Overview

• Status: Completed
• Conditions: Recurrent Implantation Failure
• Intervention / Treatment: Procedure: PRP

Detailed Description

After ethical committee approval was obtained, 150 infertile women with history of RIF gave their written consent to be included in this study. All were recruited from the outpatient clinic of Al-Baraka fertility hospital - with age below 40 yrs, body mass index (BMI) below 30 kg/m2, whose uteri were morphologically normal as confirmed by HSG and U/S to limit additional factors that may affect the results of the study - Divided into 2 comparable groups; all participants underwent antagonist protocol, oocytes retrieval, fertilization and embryo transfer; In the study group, intrauterine infusion of 0.5 to 1 ml of platelet-rich plasma (PRP) was performed 48 hrs before blastocyst transfer, pregnancy tests were done 12 days after ET.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bahrain
  • Adliya
    • Manama, Adliya, Bahrain, 15006
      • Al-BARAKA FERTILITY HOSPITAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• female infertile patients with history of recurrent implantation failure
• age below 40 yrs.,
• body mass index (BMI) below 30 kg/m2.

Exclusion Criteria:

• haematological and immunological disorders
• hormonal disorders,
• chromosomal and genetic abnormalities and uterine abnormalities (acquired or congenital) as confirmed by HSG and U/S to limit additional factors that may affect the results of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: endometrial PRP; In study group (75 patients), intrauterine infusion of PRP was done 48 hrs. before ET. PRP was prepared from autologous blood and it was made by using two steps centrifuge process. All Blastocyst transfers were performed under ultrasound guidance by one expert gynecologist with infertility fellowship. ET was performed according to American Society for Reproductive Medicine (ASRM) guidelines 2013 (Two or three embryos for each participant). On PRP infusion day, 17.5 ml of peripheral venous blood was drawn into a syringe that contains 2.5 ml of Acid Citrate and centrifuged immediately at 1200 rpm for 12 min to separate red blood cells, then plasma was centrifuged again at 3300 rpm for 7 min to obtain PRP that contained platelet 4-5 times more than peripheral blood. 0.5- 1 ml of PRP was infused into the uterine cavity with embryo transfer catheter (Wallace - Smiths, UK). On the other side, No PRP was done in control group. Pregnancy tests were done 12 days after ET.

Procedure: PRP; Platelet Rich Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with positive pregnancy test	B-hCG ; pregnancy rate	2 weeks

Collaborators and Investigators

• Sponsor: Dr. Kamal Rageh

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2017
• Primary Completion (ACTUAL): June 15, 2018
• Study Completion (ACTUAL): June 15, 2018

Study Registration Dates

• First Submitted: November 4, 2018
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (ACTUAL): September 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: IVF; implantation; Recurrent implantation failure; platelet rich plasma (PRP)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: AlBarakaBH

Drug and device information, study documents

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