<?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>IRCT20181031041519N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison  the use of dyrogesterone and steroid in IVF Cycles.</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the use of dydrogesterone and GnRH antagonists in InVitro Fertilization (IVF) cycles.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37495</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random method using a random numbers table which the researcher selects to read the numbers from top to bottom and  on one of the numbers she places her finger and moves up and down and records the numbers that consider the pair numbers for the intervention group (A) and the individual numbers for the control group (B).</study_design>
      <phase>3</phase>
      <hc_freetext>Female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A (study group): On the second day of the menstrual cycle, all patients undergo vaginal sonography, and in the absence of follicles greater than 10 mm, the treatment cycle begins. Patients receive oral progesterone or dydrogesterone (Duphaston, 20 mg daily, oral). Six days after the start of treatment, vaginal sonography will be performed. At the same time as starting dydrogesterone (2-3 cycles a day), hMG (225-150 units injected daily) is prescribed. In case of appearance, 2 follicles of 18 mm and 3 follicles of 14-15 mm in ultrasound, for the trigger, decapeptide, will be administered at 0.2 cc. It is worth mentioning that taking dydrogesterone is stopped on the trigger day. Intervention 2: Control group: Group B (control): hMG 225-150 injectable units daily) received in  2-3 cycles of menstruation and after administration of hMG, when the follicle reached 13 mm, the Cetrotide antagonist (GnRh, 0.25 mg), It is injected subcutaneously every 24 hours. In case of appearance, 2 follicles of 18 mm and 3 follicles in 14-15 mm in ultrasound, for a trigger, decapeptide, will be prescribed to 0.2 cc. And the antagonist (steroid) injection stops. 36-39 hours after decapeptide injection, ovule collection (OPU, Ovum Pick up) will be done in both groups. n (OPU, Ovum Pick up) will be done in both groups. The ovum obtained is categorized in terms of growth by the embryologist. And 2-3 days after the ICSI, embryos are graded by the number of cells and fragmentation by the specialist. In the next cycle, then in each patient, 2 embryos will be transmitted from the best embryos of good quality (embryos with high blastomeres and without fragmentation) and the embryo transfer will be carried out by one person from the infertility fellowship without knowledge of the patient groups.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyede Masoumeh Ghazi Mirsaeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Infertility Clinic,Vali Asr Hospital, ImamKhomeini Hospital Complex, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14194</zip>
        <telephone>+98 21 6693 9320</telephone>
        <email>dr_ghazi82@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>Infertility Clinic, Vali Asr Hospital, ImamKhomeini Hospital Complex, Keshavarz Blvd.,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14194</zip>
        <telephone>+98 21 6693 9320</telephone>
        <email>bhrashidi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertile patients candidates  for IVF
AMH greater than 1 ng / ml
First or second IVF cycle
The presence of both ovaries
Age less than 40 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Smoking
Presence of uterine anomalies
Adrenal insufficiency or uncontrolled thyroid
Endometriosis grade 3 or More
Couples chromosomal disorder
Underlying disorder that can lead to ovulatory dysfunction
Repeated failure of IVF</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</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: Group A (study group): On the second day of the menstrual cycle, all patients undergo vaginal sonography, and in the absence of follicles greater than 10 mm, the treatment cycle begins. Patients receive oral progesterone or dydrogesterone (Duphaston, 20 mg daily, oral). Six days after the start of treatment, vaginal sonography will be performed. At the same time as starting dydrogesterone (2-3 cycles a day), hMG (225-150 units injected daily) is prescribed. In case of appearance, 2 follicles of 18 mm and 3 follicles of 14-15 mm in ultrasound, for the trigger, decapeptide, will be administered at 0.2 cc. It is worth mentioning that taking dydrogesterone is stopped on the trigger day.</i_keyword>
      <i_keyword>Control group: Group B (control): hMG 225-150 injectable units daily) received in  2-3 cycles of menstruation and after administration of hMG, when the follicle reached 13 mm, the Cetrotide antagonist (GnRh, 0.25 mg), It is injected subcutaneously every 24 hours. In case of appearance, 2 follicles of 18 mm and 3 follicles in 14-15 mm in ultrasound, for a trigger, decapeptide, will be prescribed to 0.2 cc. And the antagonist (steroid) injection stops. 36-39 hours after decapeptide injection, ovule collection (OPU, Ovum Pick up) will be done in both groups. n (OPU, Ovum Pick up) will be done in both groups. The ovum obtained is categorized in terms of growth by the embryologist. And 2-3 days after the ICSI, embryos are graded by the number of cells and fragmentation by the specialist. In the next cycle, then in each patient, 2 embryos will be transmitted from the best embryos of good quality (embryos with high blastomeres and without fragmentation) and the embryo transfer will be carried out by one person from the infertility fellowship without knowledge of the patient groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of mature oocyte. Timepoint: Two weeks after treatment. Method of measurement: Vaginal sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>LH surge. Timepoint: Two weeks after treatment. Method of measurement: Blood test.</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>2019-02-19</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Sixth Floor, Quds Building, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
