PRP in Recurrent Implantation Failure

Not Applicable

Completed

• Conditions: Recurrent Implantation Failure

• Registration Number: NCT04085783
• Lead Sponsor: Dr. Kamal Rageh

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.

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 Timeline

• Study Start: 2017-12-03
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Study First Submitted: 2018-11-04
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-10
• Last Update Submitted: 2019-09-10
• Study First Posted: 2019-09-11
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants with positive pregnancy test	2 weeks	B-hCG ; pregnancy rate

Trial Locations

Locations (1)

Al-BARAKA FERTILITY HOSPITAL; 🇧🇭 Manama, Adliya, Bahrain