<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434547</url>
  </required_header>
  <id_info>
    <org_study_id>DrHGouda</org_study_id>
    <nct_id>NCT04434547</nct_id>
  </id_info>
  <brief_title>A RCT on the Effect of Platelets Rich Plasma in ICSI Patients With Recurrent Implantation Failure</brief_title>
  <acronym>PRP</acronym>
  <official_title>A Randomized Controlled Trial on the Effect of Adding Platelets Rich Plasma Intrauterine on the Day of Ovum Pickup in ICSI Patients With Recurrent Implantation Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Osman Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Osman Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial will be performed on 86 patients with recurrent implantation&#xD;
      failure at Dar El Teb infertility and IVF center . Patients were randomized on a 1 to 1 ratio&#xD;
      to platelets rich plasma ( PRP) group and control group.&#xD;
&#xD;
      Ovarian stimulation was achieved using highly purified urinary FSH starting on the 2 nd or&#xD;
      3rd day of the cycle . GnRH agonist ( cetrotide) 0.25 mg SC/ day was administered when the&#xD;
      leading follicle reached 14mm in mean diameter and a dose of 10000 IU of HCG was administered&#xD;
      when 3 or more follicles were 18mm or more in diameter..&#xD;
&#xD;
      Oocyte retrieval was done under ultrasound guidance and in the PRP group 1 ml of platelets&#xD;
      rich plasma was infused inside the uterus while performing the mock embryo transfer while in&#xD;
      the control group the mock embryo transfer was performed without injecting anything inside&#xD;
      the uterus .&#xD;
&#xD;
      All patients received progesterone supplementation and embryo transfer was performed 3 to 5&#xD;
      days after oocyte retrieval.&#xD;
&#xD;
      BHCG level was done 14 days after Embryo transfer and transvaginal ultrasound was done to&#xD;
      confirm pregnancy 4 weeks later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This two arm, allocation concealed ,assessor blinded randomized controlled trial is to be&#xD;
      conducted at Dar ElTeb Infertility and IVF center ,Giza,Egypt between the period between June&#xD;
      2020 and March 2021.&#xD;
&#xD;
      Eighty six patients with recurrent implantation failure were randomized in a 1 to 1 ratio to&#xD;
      platelets-rich plasma (PRP) group and the control group . Patients were randomized using&#xD;
      computer generated randomization list and sequentially numbered sealed envelopes containing&#xD;
      allocation written on a card. The randomization list and the sealed envelopes were prepared&#xD;
      by a colleague who is not directly involved in the study . The embryologists and the doctors&#xD;
      responsible for follow up of the patients after ovum pickup were blinded to received&#xD;
      treatment.&#xD;
&#xD;
      Ovarian stimulation was achieved using highly purified urinary FSH ( HPuFSH) (Fostimon,IBSA,&#xD;
      Switzerland) started on the 2nd or 3rd day of menstruation . The initial dose of HPuFSH&#xD;
      ranged between 150 and 300 IU/day depending on expected ovarian response. The dose of HPuFSH&#xD;
      was modified from stimulation day 5 in steps of 75 units every 2nd or 3rd day depending on&#xD;
      serum E2 and follicular development assessed by transvaginal ultrasound.&#xD;
&#xD;
      GnRH agonist ( cetrolix acetate) (cetrotide) 0.25mg SC/day was administered when the leading&#xD;
      follicle reached 14 mm in mean diameter and was continued until and including the day of HCG&#xD;
      administration .&#xD;
&#xD;
      A dose of 10000 IU of HCG was administered when 3 or more follicles were 18mm or more in mean&#xD;
      diameter .&#xD;
&#xD;
      Oocyte retrieval under transvaginal ultrasound guidance was performed 34 hours after HCG&#xD;
      administration .&#xD;
&#xD;
      In PRP group autologous platelets rich plasma was prepared from the blood using the two step&#xD;
      centrifuge process. Under ultrasound guidance and complete aseptic procedures ,the&#xD;
      endometrial thickness was measured then 1 ml of PRP was infused inside the uterus while&#xD;
      performing the mock embryo transfer . In the control group mock embryo transfer was performed&#xD;
      without injecting anything inside the uterus .&#xD;
&#xD;
      All the patients received progesterone vaginal pessaries ( prontogest, Marcyryl, Egypt) 400mg&#xD;
      twice daily , starting on the day of oocyte retrieval and continuing until 12 weeks gestation&#xD;
      or negative pregnancy test.&#xD;
&#xD;
      No more than 3 embryos were transferred under ultrasound guidance 3 to 5 days after oocyte&#xD;
      retrieval . B HCG level was detected in blood 14 days after Embryo transfer to confirm&#xD;
      pregnancy and transvaginal ultrasound was performed 4 weeks after embryo transfer to confirm&#xD;
      clinical pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 15, 2020</start_date>
  <completion_date type="Anticipated">March 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>Four weeks post intervention</time_frame>
    <description>The presence of a gestational sac by transvaginal ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>Four weeks post intervention</time_frame>
    <description>The number of gestational sacs detected by ultrasound divided by the number of embryos</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>Five months post intervention</time_frame>
    <description>Pregnancies continuing beyond the 20th week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abortion rate</measure>
    <time_frame>Five months post intervention</time_frame>
    <description>Pregnancies terminated before 20 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Pregnancy Outcome</condition>
  <arm_group>
    <arm_group_label>PRP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the PRP group autologous platelets rich plasma was prepared from the blood using the two step centifuge process .Under ultrasound guidance and complete aseptic procedure , 1 ml of PRP was infused inside the uterus while performing the mock embryo transfer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control group mock embryo transfer was performed without injecting anything inside the uterus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRP</intervention_name>
    <description>During the mock embryo transfer on oocyte retrieval day, 1ml of PRP was infused inside the uterus</description>
    <arm_group_label>PRP group</arm_group_label>
    <other_name>Platelets rich plasma</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with history of three or more unsuccessful IVF-ET cycles with at least two&#xD;
             good quality embryos transferred and candidates for fresh embryo transfer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Age less than 18 years or more than 35years and body mass index more than 30 kg/m2.&#xD;
&#xD;
        Patients with PCOS, endometriosis, uterine anomalies , Ashermann syndrome, chronic&#xD;
        endometritis, chromosomal abnormalities, increased peripheral NK cells, hereditary&#xD;
        thrombophylia and anti phospholipid syndrome&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hisham Gouda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant prof Cairo university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hisham Gouda, MD</last_name>
    <phone>00201001885885</phone>
    <email>Sheemeer75@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omneya Osman, MD</last_name>
    <phone>01006671777</phone>
    <email>Omna03@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Nazari L, Salehpour S, Hosseini MS, Hashemi Moghanjoughi P. The effects of autologous platelet-rich plasma in repeated implantation failure: a randomized controlled trial. Hum Fertil (Camb). 2020 Sep;23(3):209-213. doi: 10.1080/14647273.2019.1569268. Epub 2019 Feb 4.</citation>
    <PMID>30714427</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. Osman Hospital</investigator_affiliation>
    <investigator_full_name>Dr Hisham Gouda</investigator_full_name>
    <investigator_title>Assistant prof OB/GYN Cairo university</investigator_title>
  </responsible_party>
  <keyword>PRP , IVF</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434547
org study id: DrHGouda
nct id: NCT04434547
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial will be performed on 86 patients with recurrent implantation
      failure at Dar El Teb infertility and IVF center . Patients were randomized on a 1 to 1 ratio
      to platelets rich plasma ( PRP) group and control group.

      Ovarian stimulation was achieved using highly purified urinary FSH starting on the 2 nd or
      3rd day of the cycle . GnRH agonist ( cetrotide) 0.25 mg SC/ day was administered when the
      leading follicle reached 14mm in mean diameter and a dose of 10000 IU of HCG was administered
      when 3 or more follicles were 18mm or more in diameter..

      Oocyte retrieval was done under ultrasound guidance and in the PRP group 1 ml of platelets
      rich plasma was infused inside the uterus while performing the mock embryo transfer while in
      the control group the mock embryo transfer was performed without injecting anything inside
      the uterus .

      All patients received progesterone supplementation and embryo transfer was performed 3 to 5
      days after oocyte retrieval.

      BHCG level was done 14 days after Embryo transfer and transvaginal ultrasound was done to
      confirm pregnancy 4 weeks later.
This two arm, allocation concealed ,assessor blinded randomized controlled trial is to be
      conducted at Dar ElTeb Infertility and IVF center ,Giza,Egypt between the period between June
      2020 and March 2021.

      Eighty six patients with recurrent implantation failure were randomized in a 1 to 1 ratio to
      platelets-rich plasma (PRP) group and the control group . Patients were randomized using
      computer generated randomization list and sequentially numbered sealed envelopes containing
      allocation written on a card. The randomization list and the sealed envelopes were prepared
      by a colleague who is not directly involved in the study . The embryologists and the doctors
      responsible for follow up of the patients after ovum pickup were blinded to received
      treatment.

      Ovarian stimulation was achieved using highly purified urinary FSH ( HPuFSH) (Fostimon,IBSA,
      Switzerland) started on the 2nd or 3rd day of menstruation . The initial dose of HPuFSH
      ranged between 150 and 300 IU/day depending on expected ovarian response. The dose of HPuFSH
      was modified from stimulation day 5 in steps of 75 units every 2nd or 3rd day depending on
      serum E2 and follicular development assessed by transvaginal ultrasound.

      GnRH agonist ( cetrolix acetate) (cetrotide) 0.25mg SC/day was administered when the leading
      follicle reached 14 mm in mean diameter and was continued until and including the day of HCG
      administration .

      A dose of 10000 IU of HCG was administered when 3 or more follicles were 18mm or more in mean
      diameter .

      Oocyte retrieval under transvaginal ultrasound guidance was performed 34 hours after HCG
      administration .

      In PRP group autologous platelets rich plasma was prepared from the blood using the two step
      centrifuge process. Under ultrasound guidance and complete aseptic procedures ,the
      endometrial thickness was measured then 1 ml of PRP was infused inside the uterus while
      performing the mock embryo transfer . In the control group mock embryo transfer was performed
      without injecting anything inside the uterus .

      All the patients received progesterone vaginal pessaries ( prontogest, Marcyryl, Egypt) 400mg
      twice daily , starting on the day of oocyte retrieval and continuing until 12 weeks gestation
      or negative pregnancy test.

      No more than 3 embryos were transferred under ultrasound guidance 3 to 5 days after oocyte
      retrieval . B HCG level was detected in blood 14 days after Embryo transfer to confirm
      pregnancy and transvaginal ultrasound was performed 4 weeks after embryo transfer to confirm
      clinical pregnancy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Clinical pregnancy rate
time frame: Four weeks post intervention
description: The presence of a gestational sac by transvaginal ultrasound
measure: Implantation rate
time frame: Four weeks post intervention
description: The number of gestational sacs detected by ultrasound divided by the number of embryos
measure: Ongoing pregnancy rate
time frame: Five months post intervention
description: Pregnancies continuing beyond the 20th week
measure: Abortion rate
time frame: Five months post intervention
description: Pregnancies terminated before 20 weeks
arm group label: PRP group
arm group type: Experimental
description: In the PRP group autologous platelets rich plasma was prepared from the blood using the two step centifuge process .Under ultrasound guidance and complete aseptic procedure , 1 ml of PRP was infused inside the uterus while performing the mock embryo transfer
arm group label: Control group
arm group type: No Intervention
description: In the control group mock embryo transfer was performed without injecting anything inside the uterus.
intervention type: Biological
intervention name: PRP
description: During the mock embryo transfer on oocyte retrieval day, 1ml of PRP was infused inside the uterus
arm group label: PRP group
other name: Platelets rich plasma
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Hisham Gouda, MD
role: Principal Investigator
affiliation: Assistant prof Cairo university
last name: Hisham Gouda, MD
phone: 00201001885885
email: Sheemeer75@gmail.com
last name: Omneya Osman, MD
phone: 01006671777
email: Omna03@gmail.com
citation: Nazari L, Salehpour S, Hosseini MS, Hashemi Moghanjoughi P. The effects of autologous platelet-rich plasma in repeated implantation failure: a randomized controlled trial. Hum Fertil (Camb). 2020 Sep;23(3):209-213. doi: 10.1080/14647273.2019.1569268. Epub 2019 Feb 4.
PMID: 30714427
responsible party type: Principal Investigator
investigator affiliation: Dr. Osman Hospital
investigator full name: Dr Hisham Gouda
investigator title: Assistant prof OB/GYN Cairo university
sharing ipd: No