<?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>IRCT20221001056068N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of ovarian stimulation in infertile patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of ovarian stimulation in proliferative and luteal phases in an ovarian cycle (DuoStim method) in patients with poor ovarian response</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention group: In the DuoStim method, ovarian stimulation is performed in both ovarian phases. From the third day of menstruation, all poor ovarian response patients who are candidates for in vitro fertilization undergo ovulation stimulation with gonadotropin at a dose of 300 units daily with Karma brand human gonadotropin (HMG) 150 units and Sinnal brand recombinant follicle stimulation hormone (FSH) 150 units. When the follicle diameter is higher than 14 mm, gonadotropin releasing hormone (GnRH) antagonist with Steronax brand 0.25 is used daily, and when at least two follicles with a diameter of 17 mm are seen through vaginal ultrasound with volusonE6 brand ultrasound machine, Ovitrol is used to trigger the oocyte of the patients. 250 single doses are used. Before transferring to the operating room for ovulation, polymerase chain reaction (PCR) test for COVID19 is requested from the couple, and if the corona test is negative, ovulation is performed. (Proliferative phase) On the same day, a sperm sample is taken from the wife and prepared by a laboratory process and microinjection is performed by an embryologist. Then, 3 days after ovulation, vaginal ultrasound is performed again to see the follicle, and the same drugs as mentioned (HMG and recombinant FSH and then GnRH antagonist) are started and continue with Ovitrol until the trigger time. Then ovulation is done (luteal phase) and on the same day, a sperm sample is taken from the wife and prepared by a laboratory process and microinjection is done by an embryologist..</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 Compliance with ethical standards and the right to preserve the information of the research center</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Safa Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Reyhan 6 Alley, Motahari St.</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7517836363</zip>
        <telephone>009877333535655</telephone>
        <email>mina.salehi123321@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Safa Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Reyhan 6 Alley, Motahari St.</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7517836363</zip>
        <telephone>009877333535655</telephone>
        <email>mina.salehi123321@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Women who are known as patients with poor response to ovulation stimulation according to POSEIDON 3 and 4 diagnostic criteria and will undergo the necessary treatment protocols for IVF/ICSI.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Azoospermia  confirmed via a semen analysis
History of surgery on the uterus
Severe endometriosis through history and ultrasound findings
Hydrosalpinx by ultrasound or hysterosalpingography
Endocrine disorders such as diabetes, thyroid through blood biochemistry test
Body Mass Index (BMI)&gt;30
History of hysteroscopy
History of recurrent abortions in the history
History of recurrent failure of implantation (more than or equal to 3 times )</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the DuoStim method, ovarian stimulation is performed in both ovarian phases. From the third day of menstruation, all poor ovarian response patients who are candidates for in vitro fertilization undergo ovulation stimulation with gonadotropin at a dose of 300 units daily with Karma brand human gonadotropin (HMG) 150 units and Sinnal brand recombinant follicle stimulation hormone (FSH) 150 units. When the follicle diameter is higher than 14 mm, gonadotropin releasing hormone (GnRH) antagonist with Steronax brand 0.25 is used daily, and when at least two follicles with a diameter of 17 mm are seen through vaginal ultrasound with volusonE6 brand ultrasound machine, Ovitrol is used to trigger the oocyte of the patients. 250 single doses are used. Before transferring to the operating room for ovulation, polymerase chain reaction (PCR) test for COVID19 is requested from the couple, and if the corona test is negative, ovulation is performed. (Proliferative phase) On the same day, a sperm sample is taken from the wife and prepared by a laboratory process and microinjection is performed by an embryologist. Then, 3 days after ovulation, vaginal ultrasound is performed again to see the follicle, and the same drugs as mentioned (HMG and recombinant FSH and then GnRH antagonist) are started and continue with Ovitrol until the trigger time. Then ovulation is done (luteal phase) and on the same day, a sperm sample is taken from the wife and prepared by a laboratory process and microinjection is done by an embryologist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The overall percentage of fertility in the proliferative phase and the luteal phase. Timepoint: Day 14 and day 28 after the start of ovarian stimulation. Method of measurement: optical microscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The average number of metaphase 2 oocytes after ovulation in the proliferative phase and the luteal phase. Timepoint: Day 14 and day 28 after the start of ovarian stimulation. Method of measurement: optical microscope.</sec_outcome>
      <sec_outcome>The average number of oocytes after ovulation in proliferative phase and luteal phase. Timepoint: Day 14 and day 28 after the start of ovarian stimulation. Method of measurement: optical microscope.</sec_outcome>
      <sec_outcome>The average of number of 3-day-old embryos obtained after in vitro fertilization in the proliferative phase and the luteal phase. Timepoint: Day 17and day 31after the start of ovarian stimulation. Method of measurement: optical microscope.</sec_outcome>
      <sec_outcome>The average quality of 3-day-old embryos obtained in proliferative phase and luteal phase. Timepoint: Day 17and day 31after the start of ovarian stimulation. Method of measurement: optical microscope.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-11</approval_date>
        <contact_name>Research Ethics Committees of Research Ethics Committee of the "Alzahra Research Centers"</contact_name>
        <contact_address>Hezar jarib Street Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
