<?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>IRCT20150310021420N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>FSH administration for triggering final oocyte maturation in improving ART outcome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of simultanious administration of FSH and hCG for triggering on oocyte quality and ART outcome in antagonist protocol</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18779</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to Stratified Block randomization, the samples will be divided into two groups of intervention and control. The number of blocks will be 6. The mentioned list will be generated by using the "www.sealedenvelope.com" site. The random allocation list is solely available to the epidemiologist. For the Concealment of the random allocation process, treatments will be written on 110 cards, respectively. then the cards are placed inside sealed envelopes. When the physician announces the eligibility of a patient, the methodologist will provide the physician with the envelope, Blinding description: The assessor of the final outcome (oocyte quality), who is the embryologist, is unaware of the type of cycle regimen. The data analyzer is also unaware of the type of intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>femaleInfertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patients enter antagonist cycle and after frequent  follicular monitoring and defining the triggering time . When at least two oocytes were seen HCG 10000+FSH450I.U were injected. Intervention 2: Control Group: The patients enter antagonist cycle and after frequent  follicular monitoring and defining the triggering time . When atleast two oocytes were seen,  HCG 10000 was injected.</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 data set and study protocol potentially after nonidentification of patients  can be shared.

When:
6 months after publication of manuscript

To whom:
Academic and scientific researchesrs

Conditions:
It is usable by  mentioning the reference

Where to obtain:
It should be requested by Email
m_fmojtahedi@yahoo.com
Dr.Maryam farid Mojtahedi

How to obtain:
If ّit be requested by Email,it will be answered in one month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Faridmojtahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash Women's Hospital, Resalt highway, Tehranpars, Rashid Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653915981</zip>
        <telephone>+98 21 7771 9922</telephone>
        <email>m_fmojtahedi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Faridmojtahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash Women's Hospital, Resalt highway, Tehranpars, Rashid Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653915981</zip>
        <telephone>+98 21 7771 9922</telephone>
        <email>m_fmojtahedi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 18 and 38
third day FSH below10IU/ml and AFC more than 5 in each ovary
normal uterine cavity
antagonist protocol IVF cycles</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Estradiol at day of trigger more than 4500IU/l
Cancellation of oocyte retrieval due to cycle cancellation or changing to IUI
History of more than 2 failed IVF/ICSI
Severe male factor</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility, unspecified</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: The patients enter antagonist cycle and after frequent  follicular monitoring and defining the triggering time . When at least two oocytes were seen HCG 10000+FSH450I.U were injected.</i_keyword>
      <i_keyword>Control Group: The patients enter antagonist cycle and after frequent  follicular monitoring and defining the triggering time . When atleast two oocytes were seen,  HCG 10000 was injected.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oocyte quality. Timepoint: Day of ovarian puncture. Method of measurement: gardner scale by microscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 28 days after transfer. Method of measurement: vaginal ultrasound and observation of fetal heart beat.</sec_outcome>
      <sec_outcome>Ongoing pregnancy. Timepoint: after first trimester. Method of measurement: sonography and observation of alive fetus.</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>2017-02-01</approval_date>
        <contact_name>Ethics committee of School of Medicine - Tehran University of Medical Sciences</contact_name>
        <contact_address>Poorsina st - Qods st - enghelab st - Tehran-Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
