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Platelet Rich Plasma and Recurrent Implantation Failure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03996837
Enrollment
80
Registered
2019-06-25
Start date
2017-08-16
Completion date
2022-05-21
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Implantation Failure

Keywords

Platelet rich plasma, Recurrent implantation failure, Infertility, Assisted reproduction technology

Brief 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.

Detailed 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.

Interventions

OTHERIntra 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.

Sponsors

Royan Institute
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Implantation rate4-6 weeks after embryo transferThe number of gestational sacs observed, divided by the number of embryos transferred

Secondary

MeasureTime frameDescription
Ongoing pregnancy rate12 weeks after embryo transferContinued pregnancy at \> gestational week 12 or more per initiated cycle

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026