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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04085783
Other study ID # AlBarakaBH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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