Platelet Rich Plasma and Recurrent Implantation Failure

Recurrent Implantation Failure Clinical Trial

Official title:

Evaluation of the Application Platelet Rich Plasma in the Treatment of Patients With Recurrent Implantation Failure in IVF-ICSI & Freeze Embryo Transfer Cycles in Royan Institute; a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996837
• Other study ID #: PRP-RIF
• Status: Completed
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: May 21, 2022

Study information

• Verified date: January 2024
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with recurrent implantation failure. The study population consisted of infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good quality embryos transfers and are now candidate for IVF-ICSI or freeze embryo transfer cycles with and without intra uterine infusion of platelet rich plasma in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Description:

Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated. Given the importance of endometrial compliance and according to molecular studies, which indicate that endometrial growth factors in women with a history of RIF are lower than normal fertile women, PRP, along with other existing strategies, can be used to improve endometrial compliance in patients with a history of RIF. The present randomized, controlled clinical trial is proposed to determine the efficacy of PRP in the treatment of patients with RIF in the cycles of IVF-ICSI and frozen embryo transfer at Royan Institute.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 21, 2022
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy which at least four good quality embryos transfers

2. 20<Age<40

3. 19<BMI<29

4. Non endocrine, hematologic and autoimmune disorders

5. Non chromosomal and genetic abnormalities

6. Non uterine anomalies, surgical history, endometriosis, adenomyosis, hydro salpinx, uterine fibroids, Polycystic ovary syndrome

7. Having at least three good quality embryos

Exclusion Criteria:

1. Cervicitis

2. Recent fever condition

3. Use of corticosteroids (in up to 2 weeks before the procedure) or non-steroid anti-inflammatories (in up to 48 hours before procedure)

4. Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia

5. Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus

6. History of cancer

7. Patient's tendency for withdrawal

Related Conditions & MeSH terms

• Recurrence
• Recurrent Implantation Failure

Intervention

Other:
• Intra uterine infusion of platelet rich plasma
Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate	The number of gestational sacs observed, divided by the number of embryos transferred	4-6 weeks after embryo transfer
Secondary	Ongoing pregnancy rate	Continued pregnancy at > gestational week 12 or more per initiated cycle	12 weeks after embryo transfer