<?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>IRCT20140707018381N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effects of calcium ionophore on human oocyte in vitro maturation outcome</public_title>
      <acronym></acronym>
      <scientific_title>Effects of calcium ionophore on human oocyte in vitro maturation outcome, fertilization rate and embryo development</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29169</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method will be two-stage sampling methods. In the first stage, non-probability sampling method is used and in the second stage, random allocation is performed using permuted block randomization between the two intervention and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Treatment group with calcium ionophore: Each oocyte is placed in a 30-ml droplet of ionophore calcium A23187 for 15 minutes, then washed in two drops of 30 μL of the culture medium. The oocytes are then culture in an ecobar for 24-28 hours. Intervention 2: Control group: Group without treatment with ionophore calcium.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All interventions in the patient's file will be recorded and archived in the Taleghani hospital. All data obtained from this study will be published with regard to the privacy and confidentiality right of the the information of research  participants.

When:
Get started 6 months after publishing study results

To whom:
The findings of this study will be accessible to all individuals.

Conditions:
To improve pregnancy outcomes in infertility clinics

Where to obtain:
Elham Fazeli
Email: Elhamfazeli15@yahoo.com
Tel:00989112448530

How to obtain:
Data that release in the published article will be available to other people according to the journal protocol that published article (free or purchase).
In order to access data that not published in the paper, it is required to obtain the correspond author's approval and then approval of the research deputy of Shahid Beheshti University of Medical Sciences is obligatory.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Fazeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Arabi Ave, Daneshjo street, Velenjak, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 13425965</telephone>
        <email>Elhamfazeli15@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Fazeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Arabi Ave, Daneshjo street, Velenjak, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 13425965</telephone>
        <email>Elhamfazeli15@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Approval of the Ethics Committee of Shahid Beheshti University of Medical Sciences
The age of a woman is between 20-40 years old
Sperm has a normal parameter based on WHO criteria</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Endometriosis
Poly cystic ovary syndrome
Genetic disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Treatment group with calcium ionophore: Each oocyte is placed in a 30-ml droplet of ionophore calcium A23187 for 15 minutes, then washed in two drops of 30 μL of the culture medium. The oocytes are then culture in an ecobar for 24-28 hours.</i_keyword>
      <i_keyword>Control group: Group without treatment with ionophore calcium</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oocyte cytoplasmic maturation. Timepoint: After 24-28 hours, the culture was incubated at 37 ° C and 5% CO2. Method of measurement: Cell Tracker Blue staining for oocyte cytoplasmic maturity.</prim_outcome>
      <prim_outcome>Oocyte oxidative stress. Timepoint: After 24-28 hours, the culture was incubated at 37 ° C and 5% CO2. Method of measurement: Evaluation of the free radical oxygen (ROS) in cytoplasmic by staining with H2DCFDA.</prim_outcome>
      <prim_outcome>Meiotic spindle structure. Timepoint: After 24-28 hours, the culture was incubated at 37 ° C and 5% CO2. Method of measurement: Evaluation of miieotic spindle structure by staining with anti-tubulin antibody.</prim_outcome>
      <prim_outcome>Apoptosis rate. Timepoint: After 24-28 hours, the culture was incubated at 37 ° C and 5% CO2. Method of measurement: Determination of apoptosis rate by evaluating expression bax, bcl2 and caspase-3 gene by Real Time-PCR.</prim_outcome>
      <prim_outcome>Nucleation maturation. Timepoint: After 24-28 hours, the culture was incubated at 37 ° C and 5% CO2. Method of measurement: Determining the oocyte nucleus maturity by evaluating expression of MPF and MAPK by Real Time-PCR.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fertilization rate. Timepoint: 16-18 hours after ICSI. Method of measurement: Divide the total number of oocytes fertilized to the total  oocytes under ICSI.</sec_outcome>
      <sec_outcome>Cleavage rate. Timepoint: The third day after ICSI. Method of measurement: Split the total number of cleavage embryos divided into fertilized embryos.</sec_outcome>
      <sec_outcome>Embryo quility. Timepoint: The third day after ICSI. Method of measurement: Grading of embryo morphology based on the number and size of the blastomeres and the rate of fragmentation.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-28</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Faculty of medicine, Arabi Ave, Daneshjo street, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
