<?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>IRCT2017013032245N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-08</date_registration>
      <primary_sponsor>Research Institute for Islamic and Complementary Medicine (RICM)</primary_sponsor>
      <public_title>The impact of diet based on Iranian Traditional Medicine on IVF/ICSI outcomes of infertile women</public_title>
      <acronym>-</acronym>
      <scientific_title>Clinical trial comparing the effects of diet based on traditional medicine and usual diet on the results of in vitro fertilization for infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: In the order of entry to study based on a permuted blocks of size four, the patients in each four age  groups of under 30, 30-34, 35-37, and 38-40 years were randomly assigned to the intervention and control groups. The random allocation sequence was generated by an investigator who was not involved in eliciting data or conducting the study.</study_design>
      <phase>3</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. The recommended foods are those that help gestation, enhance libido, are semen producer, resolve the liver and spleen obstruction, strengthen uterine and main body organs including the brain, liver and heart and they have been used in infertility treatments. These food choices are derived from traditional medicine literature sources and are recommended to be included in patients’ meal plan (breakfast, lunch, dinner and snacks). Intervention 2: Control group: The usual daily diet in the control group for 2 to 3 months before IVF/ICSI.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>The number of ovum, mature ovum number, embryos number, embryo quality and fertilization rate were significantly higher in the intervention group than control group (for all items; P&lt;0.05). Overall pregnancy rate was significantly higher in the intervention group (35.2% vs. 12.4%; odds ratio [OR], 3.8; 95% confidence interval [CI] 1.8-8.3). The intervention group had higher rate of getting spontaneous pregnancy than the control group (20.9% vs. 2.2%; odds ratio [OR], 11.5; 95% confidence interval [CI] 2.6-50.9). Chemical pregnancy was significantly higher in the intervention group (64% vs. 27.5%; odds ratio [OR], 4.7; 95% confidence interval [CI] 1.9-11.6).</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:
Data will be sent to researchers upon request.

When:
After publication the results of study

To whom:
Researchers

Conditions:
for systematic or meta-analysis study

Where to obtain:
ِDr Mojgan Tansaz
tansaz_mojgan@yahoo.com

How to obtain:
E-mail correspondence with the principle researcher

Comments:
There are no patient names in the data file and numerical codes are used to identify them.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Alibeigi Beni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Traditional Medicine, Behest Street, Vahdat Islami Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 5563 9724</telephone>
        <email>alibeigibeni.zeinab@gmail.com</email>
        <affiliation>Iran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Tansaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Traditional Medicine, Shams Allay, Tavanir Opposite, Valiasr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 8877 3521</telephone>
        <email>tansaz_mojgan@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>infertile women with ovulatory problems or endometriosis or idiopathic  infertility and endometriosis
age 20 to 40 years
giving written consent to participate in the study
no infertility with anatomical causes
no infertility of their husbands
not having uterine myoma or hydrosalpinx
no smoking
no alcohol drinking
not diabetic</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>lack of interest or cooperation during the study,
refusal to go through IVF / ICSI.</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Diet based on traditional medicine in the intervention group for 2 to 3 months before IVF/ICSI. The recommended foods are those that help gestation, enhance libido, are semen producer, resolve the liver and spleen obstruction, strengthen uterine and main body organs including the brain, liver and heart and they have been used in infertility treatments. These food choices are derived from traditional medicine literature sources and are recommended to be included in patients’ meal plan (breakfast, lunch, dinner and snacks).</i_keyword>
      <i_keyword>Control group: The usual daily diet in the control group for 2 to 3 months before IVF/ICSI.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical pregnancy. Timepoint: 3 mounts after intervention. Method of measurement: sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Oocyt quality. Timepoint: 2-3 mounts after intervention. Method of measurement: Oocyt quality evaluation criteria.</sec_outcome>
      <sec_outcome>Embryo quality. Timepoint: 2-3 mounts after intervention. Method of measurement: Embryo quality evaluation criteria.</sec_outcome>
      <sec_outcome>Endometrium tickness. Timepoint: 2-3 mounts after intervention. Method of measurement: Sonography.</sec_outcome>
      <sec_outcome>Implantation rate. Timepoint: 2-3 mounts after intervention. Method of measurement: The number of gestational sac divided by the number of transferred embryos.</sec_outcome>
      <sec_outcome>Fertility rate. Timepoint: 2-3 mounts after intervention. Method of measurement: the number of oocytes fertilized divided by the number of oocytes inseminated.</sec_outcome>
      <sec_outcome>Chemical pregnancy. Timepoint: 2-3 mounts after intervention. Method of measurement: Serum Β-hCG meausurment.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice Chancellor for research of Iran University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Research Institute for Islamic and Complementary Medicine (RICM)</source_name>
      <source_name>Vice Chancellor for research of Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-15</approval_date>
        <contact_name>کمیته اخلاق دانشگاه ع پ ایران</contact_name>
        <contact_address>تهران - بزرگراه همت - جنب برج میلاد - دانشگاه علوم پزشکی ایران تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
