<?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>IRCT20181030041503N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-25</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of embryo transfer in two different protocol</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the consequences of freezing embryo transfer in infertile women with tamoxifen and recombinant gonadotropin group with GNRH agonist group and estradiol valerate</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48457</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: -Simple randomization.
-In this randomized clinical trial involving 192 women (18-42 years), two groups were randomly assigned.
-Method used to generate random allocation sequence by mentioning the name of the software or site used: Computer random assignment list produced with PASS software.
-We have no way to hide Allocation Concealment, Blinding description: The analyst will be unaware of the intervention and control groups.
It is not possible for patients to be blind because the type of medication prescribed to patients (injectable and oral) varies in two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group included 96 patients who were given 20 mg of tamoxifen twice daily for the third day of the cycle for five days, and HMG was given at 150 mg daily on days 6 and 8. Subsequent patient evaluation is performed on days 9 to 10 of the cycle with transvaginal ultrasound to measure the diameter of the follicle and the thickness of the endometrium. And if the thickness of the endometrium is 8 mm and the diameter of the dominant follicle is 18 mm, HCG10000 IU is injected to induce ovulation. 36 hours after HCG injection, the progesterone utrogestan (Besrogestan, Besins, Brussels, Belgium) 200 mg vaginal 200 mg three times daily or 100 mg endometriosis three times a day. Progesterone continues until the pregnancy test results. Endometrial thickness per day HCG Is checked. Intervention 2: Control group: In the control group, the OCP receives for 21 days, and on the 21st day of the cycle, one-third of the 3.75 decapeptil is prescribed. On the second day of the next cycle, estradiol is started at a dose of 4 mg and after three days it is converted to 6 mg. On the ninth day, ultrasound is performed in terms of endometrial thickness and increases to a maximum of 8 mg per day as needed. 100 ml endometrium is started three times a day. Progesterone is given for 5 days for blastocyst.</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 I'm looking into the matter</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maliheh Mahmoudinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Milad Fertility clinic, East Razi Streat, Dah e Day Square.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178631973</zip>
        <telephone>+98 51 3853 4021</telephone>
        <email>MahmoudiniamM@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nayyereh Khadem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza Hospital, Ebne Sina Streat</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178631973</zip>
        <telephone>+98 51 3801 2607</telephone>
        <email>khademn@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertile women (18-42 years old) who go to Milad Infertility Center for transfer  freezing embryo with a history of two or more failed embryo transfer.
Couples who are not severely infertile or TESE candidate (Testicular Sperm Extrection) .
may not have severe grade 3 and 4 endometriosis.
may not have fibroids&gt; 4 cm.
may not be candidates for fresh embryo transfer.
and may not have primary and secondary amenorrhea.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to remove the fetus from the freezer, ,
necrotic embryo
patient dissatisfaction during treatment to continue the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complications of attempted introduction of embryo in embryo transfer</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>The intervention group included 96 patients who were given 20 mg of tamoxifen twice daily for the third day of the cycle for five days, and HMG was given at 150 mg daily on days 6 and 8. Subsequent patient evaluation is performed on days 9 to 10 of the cycle with transvaginal ultrasound to measure the diameter of the follicle and the thickness of the endometrium. And if the thickness of the endometrium is 8 mm and the diameter of the dominant follicle is 18 mm, HCG10000 IU is injected to induce ovulation. 36 hours after HCG injection, the progesterone utrogestan (Besrogestan, Besins, Brussels, Belgium) 200 mg vaginal 200 mg three times daily or 100 mg endometriosis three times a day. Progesterone continues until the pregnancy test results. Endometrial thickness per day HCG Is checked.</i_keyword>
      <i_keyword>Control group: In the control group, the OCP receives for 21 days, and on the 21st day of the cycle, one-third of the 3.75 decapeptil is prescribed. On the second day of the next cycle, estradiol is started at a dose of 4 mg and after three days it is converted to 6 mg. On the ninth day, ultrasound is performed in terms of endometrial thickness and increases to a maximum of 8 mg per day as needed. 100 ml endometrium is started three times a day. Progesterone is given for 5 days for blastocyst.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy rate. Timepoint: 2 week after embryo transfer. Method of measurement: BHCG.</prim_outcome>
      <prim_outcome>The rate of clinical pregnancy. Timepoint: 6 weeks after embryo transfer. Method of measurement: Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ongoing pregnancy. Timepoint: Continue pregnancy for up to 12 weeks. Method of measurement: Transvaginal ultrasound.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-29</approval_date>
        <contact_name>Mashhad university of medical sciences Ethics committee</contact_name>
        <contact_address>Vice chancellor of Research, Mashhad university of Medical Sciences, Mashhad University of Medical Sciences ,University Avenue.Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
