<?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>IRCT20210216050385N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-13</date_registration>
      <primary_sponsor>Dezfoul University of Medical Sciences</primary_sponsor>
      <public_title>effect of sildenafil citrat on endometrial thickness</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of oral and vaginal sildenafil on endometrial thickness in infertile women with thin endometrium in frozen embryo transfer cycles</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54414</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Blinding description: In this double-blind study, sick people, ie infertile women, will be unaware of how the study groups are divided into two groups receiving placebo and the main drug, and also those who will perform the intervention in the clinic, ie researchers will be unaware from the distribution of study groups receiving placebo and The main drug.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention groupe 1:The second group, in addition to the estradiol treatment protocol, will be given oral sildenafil citrate tablets. Then, in the next stage of progesterone injection, 100 mg intramuscular for three to four days. Intervention 2: Intervention groupe 2: In the third group, in addition to the estradiol treatment protocol, sildenafil citrate tablets will be given to the vagina. Due to the unavailability of vaginal sildenafil, the patient is asked to moisten the oral sildenafil citrate tablet and place it in the vagina. 100 mg intramuscular for four days. Intervention 3: Control groupe 1: The first group will receives only oral estradiol 3 times a day and then in the next stage of progesterone injection for three to four days at a rate of 100 mg intramuscular.</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 There is not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Sima jannati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>corner of 15 Khordad Boulevard, Post Street</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6478135860</zip>
        <telephone>+98 61 4235 8110</telephone>
        <email>sjanati@ymail.com</email>
        <affiliation>Dezfoul University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Majidipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Corner of Justice Street, 15 Khordad Blvd., Post St.</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461665145</zip>
        <telephone>+98 61 4242 8203</telephone>
        <email>majidipour.n@dums.ac.ir</email>
        <affiliation>Dezfoul University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertile women between 39-18 years
All women who have a frozen fetus and have a history of a thin endometrium routinely prescribed medication to prepare the endometrium
The condition of the fetus returned from the freez should be  have a good quality (grade A-B)
Lack of drug sensitivity</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>39 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of endocrine disease: Diabetes - Hyperthyroidism - Hyperprolactinemia
History of hysteroscopic surgery due to intrauterine adhesions
specific cardiovascular disease
History of stroke or myocardial infarction
serious hapeatofailure or renal failure
Alcohol abuse or substance abuse
Use of donated ovum
PCOS
endometriosis</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>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groupe 1:The second group, in addition to the estradiol treatment protocol, will be given oral sildenafil citrate tablets. Then, in the next stage of progesterone injection, 100 mg intramuscular for three to four days.</i_keyword>
      <i_keyword>Intervention groupe 2: In the third group, in addition to the estradiol treatment protocol, sildenafil citrate tablets will be given to the vagina. Due to the unavailability of vaginal sildenafil, the patient is asked to moisten the oral sildenafil citrate tablet and place it in the vagina. 100 mg intramuscular for four days</i_keyword>
      <i_keyword>Control groupe 1: The first group will receives only oral estradiol 3 times a day and then in the next stage of progesterone injection for three to four days at a rate of 100 mg intramuscular</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical pregnancy. Timepoint: Three to four weeks after embryo transfer. Method of measurement: Presence of pregnancy sac in vaginal ultrasonography.</prim_outcome>
      <prim_outcome>Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: serologic labratory result BHCG≥25.</prim_outcome>
      <prim_outcome>Endometrial thickness. Timepoint: From the eleventh day of the menstrual cycle serially every other day. Method of measurement: vaginal ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Transmitted fetal quality. Timepoint: transmition day. Method of measurement: In terms of quality, it is divided into one of 3 groups A, B and C based on the number and size of embryonic cells (blastomers), increasing the pervasiveness and presence of multinucleated cells.</sec_outcome>
      <sec_outcome>Implantation rate. Timepoint: Two weeks after embryo transfer. Method of measurement: beta-HCG examination.</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>Dezfoul University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-03</approval_date>
        <contact_name>Ethics committee of dezful university of medical sciences</contact_name>
        <contact_address>Headquarters of Dezful University of Medical Sciences and Health Services, Corner of Justice Street., Post St., 15 Khordad Blvd., Dezful dezful Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
