Back to resultsPRP in Recurrent Implantation Failure
Primary Purpose
Recurrent Implantation Failure
Status
Completed
Phase
Not Applicable
Locations
Bahrain
Study Type
Interventional
Intervention
PRP
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Implantation Failure focused on measuring Recurrent implantation failure, implantation, IVF, platelet rich plasma (PRP)
Eligibility Criteria
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
Sites / Locations
- Al-BARAKA FERTILITY HOSPITAL
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
endometrial PRP
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants with positive pregnancy test
B-hCG ; pregnancy rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04085783
Brief Title
PRP in Recurrent Implantation Failure
Official Title
PRP in Recurrent Implantation Failure , Hope or Hype
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2017 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Kamal Rageh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Implantation Failure
Keywords
Recurrent implantation failure, implantation, IVF, platelet rich plasma (PRP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endometrial PRP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PRP
Intervention Description
Platelet Rich Plasma
Primary Outcome Measure Information:
Title
Number of Participants with positive pregnancy test
Description
B-hCG ; pregnancy rate
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Al-BARAKA FERTILITY HOSPITAL
City
Manama
State/Province
Adliya
ZIP/Postal Code
15006
Country
Bahrain
12. IPD Sharing Statement
Learn more about this trial
PRP in Recurrent Implantation Failure
We'll reach out to this number within 24 hrs