Platelet Rich Plasma and Recurrent Implantation Failure

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Intra uterine infusion of platelet rich plasma

About this trial

This is an interventional treatment trial for Recurrent Implantation Failure focused on measuring Platelet rich plasma, Recurrent implantation failure, Infertility, Assisted reproduction technology

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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
20<Age<40
19<BMI<29
Non endocrine, hematologic and autoimmune disorders
Non chromosomal and genetic abnormalities
Non uterine anomalies, surgical history, endometriosis, adenomyosis, hydro salpinx, uterine fibroids, Polycystic ovary syndrome
Having at least three good quality embryos

Exclusion Criteria:

Cervicitis
Recent fever condition
Use of corticosteroids (in up to 2 weeks before the procedure) or non-steroid anti-inflammatories (in up to 48 hours before procedure)
Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia
Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus
History of cancer
Patient's tendency for withdrawal

Sites / Locations

Royan InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Fresh embryo transfer with intra uterine infusion of PRP

Fresh embryo transfer without intra uterine infusion of PRP

Freeze embryo transfer with intra uterine infusion of PRP

Freeze embryo transfer without intra uterine infusion of PRP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Implantation rate

The number of gestational sacs observed, divided by the number of embryos transferred

Secondary Outcome Measures

Ongoing pregnancy rate

Continued pregnancy at > gestational week 12 or more per initiated cycle

Full Information

NCT ID

NCT03996837

First Posted

May 26, 2019

Last Updated

April 18, 2021

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT03996837

Brief Title

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

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 20, 2016 (Actual)

Primary Completion Date

November 20, 2021 (Anticipated)

Study Completion Date

November 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Implantation Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fresh embryo transfer with intra uterine infusion of PRP

Arm Type

Experimental

Arm Description

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.

Arm Title

Fresh embryo transfer without intra uterine infusion of PRP

Arm Type

No Intervention

Arm Description

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.

Arm Title

Freeze embryo transfer with intra uterine infusion of PRP

Arm Type

Experimental

Arm Description

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.

Arm Title

Freeze embryo transfer without intra uterine infusion of PRP

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Intra uterine infusion of platelet rich plasma

Intervention 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.

Primary Outcome Measure Information:

Title

Implantation rate

Description

The number of gestational sacs observed, divided by the number of embryos transferred

Time Frame

4-6 weeks after embryo transfer

Secondary Outcome Measure Information:

Title

Ongoing pregnancy rate

Description

Continued pregnancy at > gestational week 12 or more per initiated cycle

Time Frame

12 weeks after embryo transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 20<Age<40 19<BMI<29 Non endocrine, hematologic and autoimmune disorders Non chromosomal and genetic abnormalities Non uterine anomalies, surgical history, endometriosis, adenomyosis, hydro salpinx, uterine fibroids, Polycystic ovary syndrome Having at least three good quality embryos Exclusion Criteria: Cervicitis Recent fever condition Use of corticosteroids (in up to 2 weeks before the procedure) or non-steroid anti-inflammatories (in up to 48 hours before procedure) Anemia, thrombocytopenia, platelet dysfunction syndrome, hypofibrinogenemia Septicemia, active infections with Pseudomonas, Klebsiella or Enterococcus History of cancer Patient's tendency for withdrawal

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Parvaneh Afsharian, PhD

Phone

+9821- 23562000

Email

pafshar@royaninstitute.org

Facility Information:

Facility Name

Royan Institute

City

Tehran

ZIP/Postal Code

16635-148

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Parvaneh Afsharian, PhD

Phone

+9821- 23562000

Email

pafshar@royaninstitute.org

First Name & Middle Initial & Last Name & Degree

Tahereh Madani, M.D

First Name & Middle Initial & Last Name & Degree

Mehri Mashayekhi, M.D

First Name & Middle Initial & Last Name & Degree

Azar Yahyaei, M.Sc

12. IPD Sharing Statement

Plan to Share IPD

No

Recurrent Implantation Failure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial