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Autologous Intrauterine Platelet-Rich Plasma Instillation And Endometrial Scratching for Thinned Endometrium

Primary Purpose

Infertility Due to Nonimplantation

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
platlet rich plasma
endometrial scratch
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility Due to Nonimplantation

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Endometrial thickness < 7 mm under estrogen replacement therapy or repeated implantation failure Age between 18 and 38years

Exclusion Criteria:

Age < 18 and > 46 years Pregnancy Bleeding diathesis Previous uterine surgery (miomectomy, cesarean section, etc...) Platelet count < 105/μL Hemoglobin < 10 g/dL Presence of a tumor in the wound bed or metastatic disease Current diagnosis of cancer Other concomitant active infections Other factors of infertility ( PCO, tubal block, congenital anomalies, genetic malformation, male infertility)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    platelet rich plasma preparation

    endometrial scratch

    Arm Description

    About 15 ml of autologous blood from the patient was collected slowly in 20 ml syringe containing 1.5 ml anticoagulant citrate dextrose solution A (ACDA) under complete aseptic precautions. 2- Blood was mixed by swinging the syringe slowly. 3- By using 18G needle, the gathered blood was transfused into tube maintaining a slope of 45°. 4- The centrifugation step was then done by using non digital angle type centrifuge :the tube was put with water tube on the opposite side to achieve centrifuge balance. 5- The centrifugation occurred in one step by power 3600 RPM for 6 minutes. 6- The buffy coat was elevated up to the buffy coat line (Figure 1). 7- the buffy coat (2-3 ml PRP) was extracted from slim neck by tornado technique so that sunk platelets can be floated and drawn easily. 8- the remaining platelet poor plasma(PPP) was drawn using 5 cc syringe. then inserted by ovum pick up needle into subendometrium

    using scissor of hysteroscopr 3 snips was done in the fundus

    Outcomes

    Primary Outcome Measures

    Endometrial thickness
    Endometrial thickness > 7 mm measured by means of transvaginal ultrasound

    Secondary Outcome Measures

    Positive pregnancy test rate
    Positive pregnancy test rate

    Full Information

    First Posted
    September 13, 2019
    Last Updated
    January 22, 2020
    Sponsor
    Suez Canal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04240860
    Brief Title
    Autologous Intrauterine Platelet-Rich Plasma Instillation And Endometrial Scratching for Thinned Endometrium
    Official Title
    Randomized Clinical Trial Between Autologous Intrauterine Platelet-Rich Plasma Instillation And Three Snip Hysteroscopic Endometrial Scratching for Thinned Endometrium
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 23, 2020 (Anticipated)
    Primary Completion Date
    March 10, 2020 (Anticipated)
    Study Completion Date
    August 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Suez Canal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    aim of that study is to compare the effect between autologous intrauterine Platelet-Rich Plasma instillation and three snip hysteroscopic endometrial scratching for thinned endometrium.
    Detailed Description
    Embryo implantation is a very delicate and well-orchestrated process that is governed by the interaction between several maternal and embryonic factors, ultimately resulting in adherence of the blastocyst to the endometrium. For a short period of time during the normal menstrual cycle, the endometrium represents the fertile "soil" for the implanting embryo. The human endometrium undergoes complex changes, in response to circulating estrogen and progesterone, which culminate at the mid-luteal phase of the menstrual cycle when it becomes suitable to host the blastocyst. In clinical practice, a thin endometrium, unresponsive to conventional therapies, usually results in cycle cancellation and embryo cryopreservation. The evaluation of an adequate endometrial growth is performed using grey-scale ultrasound. The minimal endometrial thickness required for embryo transfer is now considered about 7 mm at the end of natural or medically induced follicular phase Local injury to the endometrium has been proposed as a means to improve implantation in women with RIF. Initial non-randomized studies showed a doubling of implantation rates after 2-4 endometrial injuries performed at different time points of the menstrual cycle in women with previous implantation failure . Following that, a number of randomized trials focusing on women with RIF have been conducted. The majority of the trials have demonstrated significant improvements in implantation rates, clinical pregnancy rates and/or live birth rates following endometrial injury performed in the preceding cycle Platelet rich plasma (PRP) represents a relatively new approach in regenerative medicine. It is obtained from patient's own blood and contains different growth factors and other biomolecules necessary for wound healing. Platelet rich plasma (PRP) therapy has accumulated considerable attention over the two last decades, mainly due to its potential ability in regenerative medicine. Platelets as a main components of the PRP, contain more than 1100 different proteins, with numerous post-translational modifications, resulting in over 1500 protein-based bioactive factors These factors include immune system messengers, growth factors, enzymes and their inhibitors and factors which can participate in tissue repair and wound healing. Another important characteristic of PRP is that represents an autologous product, which is prepared from the patient's own blood. Therefore, the use of autologous PRP eliminates any concerns about the risk of crossed contamination, disease transmission or immune reactions

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility Due to Nonimplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    platelet rich plasma preparation
    Arm Type
    Experimental
    Arm Description
    About 15 ml of autologous blood from the patient was collected slowly in 20 ml syringe containing 1.5 ml anticoagulant citrate dextrose solution A (ACDA) under complete aseptic precautions. 2- Blood was mixed by swinging the syringe slowly. 3- By using 18G needle, the gathered blood was transfused into tube maintaining a slope of 45°. 4- The centrifugation step was then done by using non digital angle type centrifuge :the tube was put with water tube on the opposite side to achieve centrifuge balance. 5- The centrifugation occurred in one step by power 3600 RPM for 6 minutes. 6- The buffy coat was elevated up to the buffy coat line (Figure 1). 7- the buffy coat (2-3 ml PRP) was extracted from slim neck by tornado technique so that sunk platelets can be floated and drawn easily. 8- the remaining platelet poor plasma(PPP) was drawn using 5 cc syringe. then inserted by ovum pick up needle into subendometrium
    Arm Title
    endometrial scratch
    Arm Type
    Active Comparator
    Arm Description
    using scissor of hysteroscopr 3 snips was done in the fundus
    Intervention Type
    Biological
    Intervention Name(s)
    platlet rich plasma
    Intervention Description
    Drug: PRP PRP subendometrial infusion Device: ovum oickup needle PRP subendometrial infusion by hysteroscopic guided ovum pickup needle day 9 of the cycle
    Intervention Type
    Procedure
    Intervention Name(s)
    endometrial scratch
    Intervention Description
    Three Snip Hysteroscopic Endometrial Scratching in luteal phase of preceeding cycle
    Primary Outcome Measure Information:
    Title
    Endometrial thickness
    Description
    Endometrial thickness > 7 mm measured by means of transvaginal ultrasound
    Time Frame
    24-48h after intervention
    Secondary Outcome Measure Information:
    Title
    Positive pregnancy test rate
    Description
    Positive pregnancy test rate
    Time Frame
    Approximately 4 weeks after treatment

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Endometrial thickness < 7 mm under estrogen replacement therapy or repeated implantation failure Age between 18 and 38years Exclusion Criteria: Age < 18 and > 46 years Pregnancy Bleeding diathesis Previous uterine surgery (miomectomy, cesarean section, etc...) Platelet count < 105/μL Hemoglobin < 10 g/dL Presence of a tumor in the wound bed or metastatic disease Current diagnosis of cancer Other concomitant active infections Other factors of infertility ( PCO, tubal block, congenital anomalies, genetic malformation, male infertility)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed M Aboelnasr, M.B.B.Ch.
    Phone
    201009988713
    Email
    Aboelnasr91@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed M Farrag, Ph.D
    Organizational Affiliation
    professor
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Elham H Madney, Ph.D
    Organizational Affiliation
    assisted professor
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Rasha E Khamiss, PH.D
    Organizational Affiliation
    lecturar
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28333034
    Citation
    Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013.
    Results Reference
    background
    PubMed Identifier
    29303234
    Citation
    Molina A, Sanchez J, Sanchez W, Vielma V. Platelet-rich plasma as an adjuvant in the endometrial preparation of patients with refractory endometrium. JBRA Assist Reprod. 2018 Mar 1;22(1):42-48. doi: 10.5935/1518-0557.20180009.
    Results Reference
    background
    PubMed Identifier
    29142450
    Citation
    Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17.
    Results Reference
    background
    PubMed Identifier
    23754314
    Citation
    Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.
    Results Reference
    background
    PubMed Identifier
    27363928
    Citation
    Shokeir T, Ebrahim M, El-Mogy H. Hysteroscopic-guided local endometrial injury does not improve natural cycle pregnancy rate in women with unexplained infertility: Randomized controlled trial. J Obstet Gynaecol Res. 2016 Nov;42(11):1553-1557. doi: 10.1111/jog.13077. Epub 2016 Jul 1.
    Results Reference
    background

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    Autologous Intrauterine Platelet-Rich Plasma Instillation And Endometrial Scratching for Thinned Endometrium

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