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Platelet Rich Plasma and Recurrent Implantation Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996837
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Recurrent Implantation Failure Other: Intra uterine infusion of platelet rich plasma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 20, 2016
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : November 20, 2021

Arm Intervention/treatment
Experimental: Fresh embryo transfer with intra uterine infusion of PRP
In IVF-ICSI cycles, ovulation will be stimulated through the standard protocol using a gonadotropin-releasing hormone agonist for all patients. 48 hours after the oocyte retrieval and ensuring that at least 3 good quality embryos are formed, patients will be randomized into two groups of with and without PRP intrauterine injection. For all patients, 2 embryos in the blastocyst stage with excellent or good quality will be transferred. One milliliter PRP will be injected into the patients' uterine cavity using an embryo transfer catheter (Labotect Gmbh, Labor-Technik-Gottingen Kampweg 12, 37124 Rosdorf, Germany) 48 hours before embryo transfer. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections.
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.

No Intervention: Fresh embryo transfer without intra uterine infusion of PRP
In IVF-ICSI cycles, ovulation will be stimulated through the standard protocol using a gonadotropin-releasing hormone agonist for all patients. 48 hours after the oocyte retrieval and ensuring that at least 3 good quality embryos are formed, patients will be randomized into two groups of with and without PRP intrauterine injection. For all patients, 2 embryos in the blastocyst stage with excellent or good quality will be transferred. One milliliter PRP will be injected into the patients' uterine cavity using an embryo transfer catheter (Labotect Gmbh, Labor-Technik-Gottingen Kampweg 12, 37124 Rosdorf, Germany) 48 hours before embryo transfer. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections.
Experimental: Freeze embryo transfer with intra uterine infusion of PRP
In frozen embryos transfer cycles, the endometrium of all patients will be prepared through the standard protocol using a gonadotropin-releasing hormone agonist. Following this process, 2 embryos in the blastocyst stage with good or excellent quality will be transferred. It is worth mentioning that in 48 hours prior to the embryo transfer; 1 mL of PRP will be injected into the uterine cavity using an embryo transfer catheter. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections.
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.

No Intervention: Freeze embryo transfer without intra uterine infusion of PRP
In frozen embryos transfer cycles, the endometrium of all patients will be prepared through the standard protocol using a gonadotropin-releasing hormone agonist. Following this process, 2 embryos in the blastocyst stage with good or excellent quality will be transferred. It is worth mentioning that in 48 hours prior to the embryo transfer; 1 mL of PRP will be injected into the uterine cavity using an embryo transfer catheter. In order to eliminate the effects of catheter insertion, the same catheter will be applied to the patients in the control group 48 hours before the embryo transfer without any injections.



Primary Outcome Measures :
  1. Implantation rate [ Time Frame: 4-6 weeks after embryo transfer ]
    The number of gestational sacs observed, divided by the number of embryos transferred


Secondary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 12 weeks after embryo transfer ]
    Continued pregnancy at > gestational week 12 or more per initiated cycle



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996837


Contacts
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Contact: Parvaneh Afsharian, PhD +9821- 23562000 pafshar@royaninstitute.org

Locations
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Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of, 16635-148
Contact: Parvaneh Afsharian, PhD    +9821- 23562000    pafshar@royaninstitute.org   
Principal Investigator: Tahereh Madani, M.D         
Principal Investigator: Mehri Mashayekhi, M.D         
Sub-Investigator: Azar Yahyaei, M.Sc         
Sponsors and Collaborators
Royan Institute
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT03996837    
Other Study ID Numbers: PRP-RIF
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royan Institute:
Platelet rich plasma
Recurrent implantation failure
Infertility
Assisted reproduction technology