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IRCT20080831001141N37 IRCT 2021-01-06 ROYAN Institute Platelet rich plasma and recurrent implantation failure PRP-RIF Evaluation of the application platelet rich plasma in the treatment of patients with recurrent implantation failure in IVF-ICSI & freeze embryo transfer cycles 2017-08-23 anticipated 40 Complete https://irct.ir/trial/53127 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 8. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 40 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope. N/A recurrent implantation failure. Intervention 1: Intervention group: The group of embryo transfer (fresh and or freeze) with intra uterine infusion of platelet rich plasma (PRP). In in vitro fertilization cycles, ovarian stimulation will be performed through the standard protocol using gonadotropin-releasing hormone (GnRH) agonist. In freeze embryo transfer cycles, the endometrial preparation will be performed through the standard protocol using GnRH agonist. One milliliter of PRP will be injected into the patients’ uterine cavity using an embryo transfer catheter, 48 hours before embryo transfer. Intervention 2: Control group: The group of embryo transfer (fresh and or freeze) without intra uterine infusion of PRP. In in vitro fertilization cycles, ovarian stimulation will be performed through the standard protocol using GnRH agonist. In freeze embryo transfer cycles, the endometrial preparation will be performed through the standard protocol using GnRH agonist. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients’ uterine cavity without any injections, 48 hours before the embryo transfer. Yes - There is a plan to make this available What will be shared: Clinical study report (published article) When: After the publication of the article To whom: Available to the public. Conditions: Scientific use by citing the source. Where to obtain: Dr. Mehri Mashayekhy Email: dr.mashayekhy@yahoo.com How to obtain: Request via e-mail Comments:
public Mehri Mashayekhy
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 dr.mashayekhy@yahoo.com ROYAN Institute scientific Mehri Mashayekhy
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 dr.mashayekhy@yahoo.com ROYAN Institute Iran (Islamic Republic of) Infertile women with a history of recurrent implantation failure Age 20-40 years Body Mass Index 19-29 Kg/m2 Having at least three good quality embryos 20 years 40 years Female Women with hematologic and autoimmune disorders Couples with chromosomal and genetic abnormalities Women with uterine anomalies Women with uterine and ovaries surgical history Women with endometriosis and adenomyosis Women with hydrosalpinx Women with uterine fibroids Women with recurrent abortion history Cervicitis History of fever condition (in up to 2 weeks before the intervention) Use of corticosteroids (in up to 2 weeks before the intervention) or non-steroid anti-inflammatories (in up to 48 hours before the intervention) Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus History of cancer N97.9 Female infertility, unspecified Treatment - Other Treatment - Other Intervention group: The group of embryo transfer (fresh and or freeze) with intra uterine infusion of platelet rich plasma (PRP). In in vitro fertilization cycles, ovarian stimulation will be performed through the standard protocol using gonadotropin-releasing hormone (GnRH) agonist. In freeze embryo transfer cycles, the endometrial preparation will be performed through the standard protocol using GnRH agonist. One milliliter of PRP will be injected into the patients’ uterine cavity using an embryo transfer catheter, 48 hours before embryo transfer. Control group: The group of embryo transfer (fresh and or freeze) without intra uterine infusion of PRP. In in vitro fertilization cycles, ovarian stimulation will be performed through the standard protocol using GnRH agonist. In freeze embryo transfer cycles, the endometrial preparation will be performed through the standard protocol using GnRH agonist. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients’ uterine cavity without any injections, 48 hours before the embryo transfer. Live birth rate; live birth is defined in which a live fetus is delivered beyond 20 completed weeks of gestational. Timepoint: Only once; at least 20 weeks after embryo transfer. Method of measurement: Clinical information. NCT03996837 مرکز ثبت کارآزمایی های بالينی ايالات متحده آمريکا (WWW.clinicaltrial.gov) ROOYAGEN company Approved 2017-08-15 Ethics Committee of Royan Institute Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway. Tehran Tehran Iran (Islamic Republic of)