<?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>IRCT20180908040964N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-31</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparision The Effect of Minimal stimulation and double stimulation protocol in poor ovarian response in ICSI cycle</public_title>
      <acronym></acronym>
      <scientific_title>Comparision The Effect of Minimal stimulation and double stimulation protocol in poor ovarian response in ICSI cycle</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35324</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use the numerical random number table to choose the numbers, for example, if the sample size is two digits. First, select a two-digit number completely randomly, for example by placing the pencil tip, and then go ahead and select two-digit numbers to get the required number, Blinding description: This is double-blind study, that the participants do not know which of the two control or test groups belong, and also the observers (researchers) do not know who the group is.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patients with poor ovarian response.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: In a double-stimulation protocol based on the Shanghai protocol, Qualified women entered the study in the first phase from the third day of the monthly cycle will receive a daily dose of 25 mg  cholomifen citrate for up to a stimilation day. At the same time, letrozole at a dose of 2.5 mg per day from the third day for four days at 150 units, every other day will start. And will receive HMG on the 10th day. When at least 3 follicules have reached 18 mm or a follicle reached  20 mm, the triggering of oocyte with an GNRH agonist will start. 32 to 36 hours after an agonist GNRH injection  search and retrieve oocytes from transvaginal sonography will begin and follicles less than 10 mm will remain to second phase in the luteal phase. After ultrasonography, the second phase of stimulition depends on presence of at least 2 anthral follicles with a size of 2 to 8 mm. At this stage 225 Unit HMG  with 2.5 mg Letrozole is prescribed daily from the day of recovery of oocyte or one day later. And when the dominant follicle reached 12mm, Letrozole is discontinued and daily administration of medroxyprogesterone acetate at a dose of 10 mg for 3 days will continue for patients with follicles up to 14 cm. And when at least 3 follicules have reached 18 mm or a follicle reached  20 mm,the triggering of oocyte with an GNRH agonist will start again. Intervention 2: Intervention group: In the minimum protocol, colomibsin citrate is prescribed from day 2 to day 5 of the monthly cycle with a dose of 100 mg / day. From day four, 150 HMG units are prescribed. The GNRH antagonist is administered when the dominant follicle reaches 13 or higher and continues until the final trigger day. The ovulation stimulation is performed when the dominant follicle reaches 17 mm.In this HCG recombinant mcg is prescribed.</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:
In this study, the results of the study  based on  the initial outcome Will be shared. All of the data can be shared after unidentifiable Participants

When:
Without restriction

To whom:
All researchers

Conditions:
With permission from the author responsible

Where to obtain:
Email to author responsible

How to obtain:
Email to author responsible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sediqeh Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani hospital, Yaman st., Velenjak, Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2243 2558</telephone>
        <email>shosseini@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sediqeh Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani hospital, Yaman st., Velenjak, Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2243 2558</telephone>
        <email>shosseini@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In these individuals, the previous cycle was canceled due to insufficient ovarian response. After ovarian stimulation in the previous cycle, less than three follicles and after puncture, less than one ovum were obtained.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complication associated with artificial fertilization, 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 group1: In a double-stimulation protocol based on the Shanghai protocol, Qualified women entered the study in the first phase from the third day of the monthly cycle will receive a daily dose of 25 mg  cholomifen citrate for up to a stimilation day. At the same time, letrozole at a dose of 2.5 mg per day from the third day for four days at 150 units, every other day will start. And will receive HMG on the 10th day. When at least 3 follicules have reached 18 mm or a follicle reached  20 mm, the triggering of oocyte with an GNRH agonist will start. 32 to 36 hours after an agonist GNRH injection  search and retrieve oocytes from transvaginal sonography will begin and follicles less than 10 mm will remain to second phase in the luteal phase. After ultrasonography, the second phase of stimulition depends on presence of at least 2 anthral follicles with a size of 2 to 8 mm. At this stage 225 Unit HMG  with 2.5 mg Letrozole is prescribed daily from the day of recovery of oocyte or one day later. And when the dominant follicle reached 12mm, Letrozole is discontinued and daily administration of medroxyprogesterone acetate at a dose of 10 mg for 3 days will continue for patients with follicles up to 14 cm. And when at least 3 follicules have reached 18 mm or a follicle reached  20 mm,the triggering of oocyte with an GNRH agonist will start again.</i_keyword>
      <i_keyword>Intervention group: In the minimum protocol, colomibsin citrate is prescribed from day 2 to day 5 of the monthly cycle with a dose of 100 mg / day. From day four, 150 HMG units are prescribed. The GNRH antagonist is administered when the dominant follicle reaches 13 or higher and continues until the final trigger day. The ovulation stimulation is performed when the dominant follicle reaches 17 mm.In this HCG recombinant mcg is prescribed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of follicles. Timepoint: From the tenth day of the cycle. Method of measurement: sonography.</prim_outcome>
      <prim_outcome>Number of recovered oocytes. Timepoint: Oocyte recovery day. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Number of canceled cycles. Timepoint: Oocyte recovery da. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Number of embryo. Timepoint: 5 days after Oocyte recovery. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Embryo grading. Timepoint: 5 days after Oocyte recovery. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Transmitted embryos. Timepoint: Transfer day. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Pregnancy rate. Timepoint: Two weeks after transfer. Method of measurement: blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-29</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Velenjak, Yaman St, Chamran highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
