<?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>IRCT20220921056008N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of myo-inositol on PCOS</public_title>
      <acronym></acronym>
      <scientific_title>Effect of myo-inositol on the expression of survivin and caspase 3&amp;7 genes in granulosa cells and the level of biochemical factors of follicular fluid and its relation on oocytes and embryos quality in patients with PCOs undergoing ICSI treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66005</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: In order to avoid biased answers, PCOS patients were divided into two groups with equal numbers by a simple random method in such a way that 60 beads are placed in a box numbered from 1 to 60 and from each number There are 1 beads in the box. After accepting each patient and after obtaining informed consent, the treating doctor randomly removes one of the beads inside the box (without seeing the contents of the box) and in this way the people are classified into different groups, so that Odd numbers belong to the first intervention group (Inositol) and even numbers belong to the second intervention group (Acidfolic), Blinding description: The type of research is double-blind and only the researcher knows how to group the patients. The type of drug regimen is presented to the patient by the doctor, but both the doctor and the patient are not in the process of dividing the research intervention groups, and only the researcher is in the process of dividing the patients in It is groups. The method of blinding will be in such a way that the patient is unaware of the type of treatment he will receive and the control group will receive a placebo. After dividing the participants into experimental groups and the control group, the method of performing the exercises and the exact duration of the exercises will be explained to the volunteers to participate in the research. They declare themselves to participate in the research. The conditions for entering the exam include having at least one year of infertility due to female causes (polycystic ovary syndrome) and being in good health in terms of other diseases.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:This group includes 30 patients with polycystic ovary syndrome who were candidates for infertility treatment with ICSI according to the opinion of the gynecologist. These patients received 2000 mg of inositol daily during the ICSI (implantation) cycle for three weeks (FairhavenHealth- (IRAN company) along with 1 mg of folic acid (Raha-Iran company). Then, after ovarian puncture, follicular fluid and granulosa cells and eggs are checked in terms of chemical and chemical parameters. Intervention 2: Control group: This group includes 30 patients with polycystic ovary syndrome who are candidates for infertility treatment with ICSI according to the opinion of the gynecologist. During the ICSI (embryo implantation) cycle, these patients receive one milligram of folic acid daily (Reha company) for three weeks. -Iran) are consumed, then after ovarian puncture, follicular fluid and granulosa cells and other biochemical and hormonal parameters as well as the quality of eggs are checked.</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 information related to potential data can be shared after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in universities and scientific institutions

Conditions:
Provide a relevant university degree

Where to obtain:
z_yazdanpanah68@yahoo.com

How to obtain:
After receiving the request via email, the data will be sent within a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab Yazdanpanah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zomorrod building.  Alley 52. 19th Street</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۷۱۳۶۵۹۴۳۷</zip>
        <telephone>+98 25 3760 8379</telephone>
        <email>zyazdanpanah@piau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Heydari Nasrabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Parand branch. Bahonar Blvd.Parand city.Kilometer 32 of Tehran Saveh highway</address>
        <city>Parand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۷۶۱۳۹۶۳۶۱</zip>
        <telephone>+98 21 5673 3001</telephone>
        <email>heydarimitra45@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>PCOS diagnostic criteria based on the Rotterdam consensus</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Male factor infertility. Cushing syndrome. Congenital adrenal hyperplasia. Thyroid dysfunction, hyperprolactinemia, androgen secretion neoplasia, diabetes mellitus</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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:This group includes 30 patients with polycystic ovary syndrome who were candidates for infertility treatment with ICSI according to the opinion of the gynecologist. These patients received 2000 mg of inositol daily during the ICSI (implantation) cycle for three weeks (FairhavenHealth- (IRAN company) along with 1 mg of folic acid (Raha-Iran company). Then, after ovarian puncture, follicular fluid and granulosa cells and eggs are checked in terms of chemical and chemical parameters</i_keyword>
      <i_keyword>Control group: This group includes 30 patients with polycystic ovary syndrome who are candidates for infertility treatment with ICSI according to the opinion of the gynecologist. During the ICSI (embryo implantation) cycle, these patients receive one milligram of folic acid daily (Reha company) for three weeks. -Iran) are consumed, then after ovarian puncture, follicular fluid and granulosa cells and other biochemical and hormonal parameters as well as the quality of eggs are checked</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of gene expression of caspase 3 and 7 and survivin. Timepoint: After ovarian puncture. 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-31</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Varamin-Pishva branch</contact_name>
        <contact_address>Islamic Azad University, Parand branch.Parand city - Bahonar boulevard .Kilometer 32 of Tehran Saveh highway. Parand Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
