<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20101115005181N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Study of the expression of genes involved in the process of death in oocytes in four groups of patients undergoing ovulation stimulation cycle with four therapies.</public_title>
      <acronym></acronym>
      <scientific_title>Study of the expression of genes involved in the process of apoptosis in cellulose cells in four groups of patients under the cycle of ovulation stimulation with antagonist or agonist GNRH with HP-FSH or FSH recombinant.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Female Infertility.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: 20 infertile patients who were stimulated using the Gnrh agonist ampoule (Cinafact) of Cinagen Company, from the 21th  day of previous cycle , 20 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (HP) of  Cinagen company from the third day of menstrual cycle, are administrated  for at least 10 days. Intervention 2: The second intervention group: 20 infertile patients who were stimulated using the Gnrh agonist ampoule (Cinafact) of Cinagen Company, from the 21th  day of previous cycle , 20 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (Recombinant) of  Cinagen company from the third day of menstrual cycle, are administrated  for at least 10 days. Intervention 3: The third intervention group: 20 infertile patients who were stimulated using the Gnrh antagonist ampoule (cetrotide) of Merck Company, from the 6th day of induction ovulation, 0.25 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (HP) of  Cinagen company from the third day of menstrual cycle, are administrated  for at least 10 days. Intervention 4: The Fourth intervention group: 20 infertile patients who were stimulated using the GnRH antagonist ampoule (cetrotide) of Merck Company, from the 6th day of induction ovulation, 0.25 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (recombinant) of  Cinagen company from the third day of the menstrual cycle, are administrated for at least 10 days. In all intervention groups of 1-4; The eggs are aspirated from the follicular fluid and rinsed several times, then a drop of hyaluronidase is added to them and the cumulus is separated.Gene extract from Cumulus,  At this stage, first RNA is extracted and then C DNA; It is synthesized and used; Gene expression evaluation is used using real-time PCR method.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Azizollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>IVF Labratoary, Vali- Asr Hospital, Blvd Keshavarz.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6658 1616</telephone>
        <email>saeedazizollahi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Batool Hossein Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali-e-Asr Reproductive Health Research Center, Imam Hospital Complex, Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6658 1616</telephone>
        <email>bhrashidi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of 20- 30 years old.
Normal response to induction of ovulation.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>unexplained infertility Cause
Azoospermia
Ovarian hyper stimulation Syndrome</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility associated with anovulation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: 20 infertile patients who were stimulated using the Gnrh agonist ampoule (Cinafact) of Cinagen Company, from the 21th  day of previous cycle , 20 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (HP) of  Cinagen company from the third day of menstrual cycle, are administrated  for at least 10 days.</i_keyword>
      <i_keyword>The second intervention group: 20 infertile patients who were stimulated using the Gnrh agonist ampoule (Cinafact) of Cinagen Company, from the 21th  day of previous cycle , 20 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (Recombinant) of  Cinagen company from the third day of menstrual cycle, are administrated  for at least 10 days.</i_keyword>
      <i_keyword>The third intervention group: 20 infertile patients who were stimulated using the Gnrh antagonist ampoule (cetrotide) of Merck Company, from the 6th day of induction ovulation, 0.25 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (HP) of  Cinagen company from the third day of menstrual cycle, are administrated  for at least 10 days.</i_keyword>
      <i_keyword>The Fourth intervention group: 20 infertile patients who were stimulated using the GnRH antagonist ampoule (cetrotide) of Merck Company, from the 6th day of induction ovulation, 0.25 IU subcutaneous daily up to 36 hours before oocyte pick up and 225 units FSH (recombinant) of  Cinagen company from the third day of the menstrual cycle, are administrated for at least 10 days. In all intervention groups of 1-4; The eggs are aspirated from the follicular fluid and rinsed several times, then a drop of hyaluronidase is added to them and the cumulus is separated.Gene extract from Cumulus,  At this stage, first RNA is extracted and then C DNA; It is synthesized and used; Gene expression evaluation is used using real-time PCR method.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maturation of Oocyte. Timepoint: 36 hours after the last administration of treatment. Method of measurement: Electronic Microscope.</prim_outcome>
      <prim_outcome>Fertilization rate. Timepoint: 24 hours after intra cytoplasmic sperm injection. Method of measurement: Electronic Microscope.</prim_outcome>
      <prim_outcome>Rate of Embryo development. Timepoint: The third day of intra cytoplasmic sperm injection. Method of measurement: Electronic Microscope.</prim_outcome>
      <prim_outcome>The evaluation of Gene  expression of HAS-2, BAX, BCL-2, VCAN, ALCAM, R PTGS-2 in cumulus of oocyte. Timepoint: The day of pick up ovum. Method of measurement: Real time PCR.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-02</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Sixth floor, Deputy of Research and Technology, Central University Organization, Quds Street, , Keshavarz Boulevard, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
