PRP in Recurrent Implantation Failure

NCT04085783 | Completed DMC

• 1 other identifier: AlBarakaBH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Implantation Failure

Keywords

Recurrent implantation failure; implantation; IVF; platelet rich plasma (PRP)

Outcome Measures

Primary Outcomes (1)

• Number of Participants with positive pregnancy test

  B-hCG ; pregnancy rate

  2 weeks

Study Arms (1)

endometrial PRP

EXPERIMENTAL

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

Interventions

PRP PROCEDURE

Platelet Rich Plasma

endometrial PRP

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Kamal Rageh: lead

Study Sites (1)

Al-BARAKA FERTILITY HOSPITAL

Manama, Adliya, 15006, Bahrain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical director

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: September 11, 2019
• Study Start: December 3, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

BA (1)