Clinical trial NCT03996837: Platelet Rich Plasma and Recurrent Implantation Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Implantation Failure
Keywords: Platelet rich plasma
Recurrent implantation failure
Infertility
Assisted reproduction technology
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2019-06-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implantation rate
timeFrame: 4-6 weeks after embryo transfer
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 weeks after embryo transfer
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
References: