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Completed

NCT Number: NCT04085783

PRP in Recurrent Implantation Failure

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.

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Key information

Conditions

Recurrent Implantation Failure

Age range

22 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al-BARAKA FERTILITY HOSPITAL

Manama, Adliya, 15006, Bahrain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Procedure

Platelet Rich Plasma

Primary outcomes

  1. Number of Participants with positive pregnancy test

    Time frame: 2 weeks

    B-hCG ; pregnancy rate

Sponsors and collaborators

Lead sponsor

Dr. Kamal Rageh

Other

Registry information

Official study title

PRP in Recurrent Implantation Failure , Hope or Hype

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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