<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/NCT04434495</url>
  </required_header>
  <id_info>
    <org_study_id>DrOsmanH</org_study_id>
    <nct_id>NCT04434495</nct_id>
  </id_info>
  <brief_title>Outcome of Platelet Rich Plasma in ICSI Patients, a Randomized Controlled Trial</brief_title>
  <official_title>Outcome of Platelet Rich Plasma Injection in ICSI Patients, a Randomized Controlled Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      2 groups randomized to PRP injectioninto uterine cavity at mock embryo transfer, and a&#xD;
      control group with only mock embryo transfer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants are allocated in two groups ( randomized). Study is conducted in Dar El Teb&#xD;
      infertility and IVF centre, Egypt. Normoresponder patients (9-15 mature follicles on day of&#xD;
      HCG administration) and candidates for fresh embryo transfer are recruited to the study. 788&#xD;
      patients will be randomized on the day of ovum pick up in a 1 to 1 ratio to platelet rich&#xD;
      plasma (PRP) group and control group. Patients wee randomized using computer generated&#xD;
      randomization list and sequentially numbered sealed envelopes containing allocation&#xD;
      information written on a card. The embryologist and doctors responsible for follow up after&#xD;
      ovum pick up aew blinded to received treatment. Ovarian stimunlation is achieved by highly&#xD;
      purified urinary FSH (Fostimon, IBSA, Switzerland)started on the 2nd or 3rd day of&#xD;
      menstruation. The initial dose ranged between 150-300IU/d depending on expected ovarian&#xD;
      response and serum E2 level. GnRH antagonist (Cetrotide, Serono international, Geneva,&#xD;
      Switzerland) 0.25mgSC/day will be give when the leading follicle is 14mm and continued till&#xD;
      day of HCG. 10,000 IU HCG will be given when 3 or more follicles are 18mm on mean diameter.&#xD;
      Oocyte retrieval will be performed 34-36 hours after HCG administration. In PRP group, 1 ml&#xD;
      autologous PRP prepared from blood of participants and injected under ultrasound guidance&#xD;
      inside the uterus while performing the mock embryo transfer. In control group, mock embryo&#xD;
      transfer was performed without injecting anything inside the uterus. All participants will&#xD;
      receive progesterone vaginal pessaries (Prontogest, Marcyrl, Egypt) 400 mg twicw daily,&#xD;
      starting on day of oocyte retrieval till 12weeks gestation or negative pregnancy test. No&#xD;
      more than 3 embryos will be transferred2-5 days after oocyte retrival. B HCG levels will be&#xD;
      measured in blood 14 days after HCGadministration. Transvaginal ultrasound will be performed&#xD;
      4 weeks after embryo transfer to confirm 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">April 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 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 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 transferred</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>Five months post intervention</time_frame>
    <description>Number of continued pregnancies beyond 20 weeks gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abortion rate</measure>
    <time_frame>Five months post intervention</time_frame>
    <description>Number of pregnancies terminated before 20 weeks gestation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">788</enrollment>
  <condition>Pregnancy Outcome</condition>
  <arm_group>
    <arm_group_label>PRP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mock embryo transfer and PRP injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>only mock embryo transfer</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRP</intervention_name>
    <description>PRP injection into uterine cavity</description>
    <arm_group_label>PRP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normoresponder patients (i.e. patients with 9 to 15 mature follicles on the day of HCG&#xD;
             administration ) with expected good reproductive outcomes of IVF-ET and candidates for&#xD;
             fresh embryo transfer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years and more than 35 years Body mass index more than 30kg/m2 Serum&#xD;
             progesterone level less than 1.5 ng/ml on the trigger day Smoking Moreover, patients&#xD;
             with previous IVF cycle, PCOS ( polycystic ovarian syndrome), pelvic inflammatory&#xD;
             disease, endometriosis, uterine anomalies, Ashermann syndrome, chronic endometritis,&#xD;
             chromosomal anomalies, increased peripheral NK cells, hereditary thrombophylia and&#xD;
             antiphospholipid syndrome were excluded from the study&#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>Sheemer75@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omneya Osman, MD</last_name>
    <phone>00201006671777</phone>
    <email>Omna03@gmail.com</email>
  </overall_contact_backup>
  <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>Cairo University</investigator_affiliation>
    <investigator_full_name>Dr Hisham Gouda</investigator_full_name>
    <investigator_title>Assistant Professor</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/NCT04434495
org study id: DrOsmanH
nct id: NCT04434495
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
2 groups randomized to PRP injectioninto uterine cavity at mock embryo transfer, and a
      control group with only mock embryo transfer.
Participants are allocated in two groups ( randomized). Study is conducted in Dar El Teb
      infertility and IVF centre, Egypt. Normoresponder patients (9-15 mature follicles on day of
      HCG administration) and candidates for fresh embryo transfer are recruited to the study. 788
      patients will be randomized on the day of ovum pick up in a 1 to 1 ratio to platelet rich
      plasma (PRP) group and control group. Patients wee randomized using computer generated
      randomization list and sequentially numbered sealed envelopes containing allocation
      information written on a card. The embryologist and doctors responsible for follow up after
      ovum pick up aew blinded to received treatment. Ovarian stimunlation is achieved by highly
      purified urinary FSH (Fostimon, IBSA, Switzerland)started on the 2nd or 3rd day of
      menstruation. The initial dose ranged between 150-300IU/d depending on expected ovarian
      response and serum E2 level. GnRH antagonist (Cetrotide, Serono international, Geneva,
      Switzerland) 0.25mgSC/day will be give when the leading follicle is 14mm and continued till
      day of HCG. 10,000 IU HCG will be given when 3 or more follicles are 18mm on mean diameter.
      Oocyte retrieval will be performed 34-36 hours after HCG administration. In PRP group, 1 ml
      autologous PRP prepared from blood of participants and injected under ultrasound guidance
      inside the uterus while performing the mock embryo transfer. In control group, mock embryo
      transfer was performed without injecting anything inside the uterus. All participants will
      receive progesterone vaginal pessaries (Prontogest, Marcyrl, Egypt) 400 mg twicw daily,
      starting on day of oocyte retrieval till 12weeks gestation or negative pregnancy test. No
      more than 3 embryos will be transferred2-5 days after oocyte retrival. B HCG levels will be
      measured in blood 14 days after HCGadministration. Transvaginal ultrasound will be 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 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 transferred
measure: Ongoing pregnancy rate
time frame: Five months post intervention
description: Number of continued pregnancies beyond 20 weeks gestation
measure: Abortion rate
time frame: Five months post intervention
description: Number of pregnancies terminated before 20 weeks gestation
arm group label: PRP group
arm group type: Experimental
description: mock embryo transfer and PRP injection
arm group label: control group
arm group type: No Intervention
description: only mock embryo transfer
intervention type: Biological
intervention name: PRP
description: PRP injection into uterine cavity
arm group label: PRP group
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: Sheemer75@gmail.com
last name: Omneya Osman, MD
phone: 00201006671777
email: Omna03@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Dr Hisham Gouda
investigator title: Assistant Professor
sharing ipd: No