PRP in Recurrent Implantation Failure

Recurrent Implantation Failure Clinical Trial

Official title:

PRP in Recurrent Implantation Failure , Hope or Hype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085783
• Other study ID #: AlBarakaBH
• Status: Completed
• Phase: N/A
• Start date: December 3, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: September 2019
• Source: Al Baraka Fertility Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrent Implantation Failure

Intervention

Procedure:
• PRP
Platelet Rich Plasma

Locations

Country	Name	City	State
Bahrain	Al-BARAKA FERTILITY HOSPITAL	Manama	Adliya

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Kamal Rageh

Country where clinical trial is conducted

Bahrain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with positive pregnancy test	B-hCG ; pregnancy rate	2 weeks