<?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>IRCT20160524028038N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-14</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of sildenafil and melatonin on fertility outcomes in women with poor ovarian response</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of sildenafil plus melatonin on fertility outcomes in infertile women with poor ovarian response undergoing assisted reproductive treatment.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67593</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A، B ، C ، D) for the allocation of subjects to intervention (A، B ، C) and control (D) groups will be used.</study_design>
      <phase>3</phase>
      <hc_freetext>Female infertility due to poor ovarian response.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Sildenafil (sildenafil citrate 25 mg daily; Visarsin) starting from the first day of the cycle until the day of egg retrieval) along with Inofolic (Inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days. Intervention 2: Intervention group B: Melatonin (3 mg melatonin tablets daily; Razak Pharmaceutical Company, Iran) starting from the first day of the cycle until the day of egg retrieval along with inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days. Intervention 3: Intervention group C: Melatonin (daily 3 mg of melatonin tablets (Razak Pharmaceutical Company, Iran), starting from the first day of the cycle until the day of egg retrieval with sildenafil (daily 25 mg of sildenafil citrate; Visarsin) starting from the first day of the cycle until the day of egg retrieval with inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days. Intervention 4: Control group: Inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Street, Bandarabbas, Hormozgan</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919915519</zip>
        <telephone>+98 76 3333 0755</telephone>
        <email>Maryamazizikut86@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan</address>
        <city>Bandarabbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7916839319</zip>
        <telephone>076333666365</telephone>
        <email>maryamazizikut86@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged 18 to 45 years
Not using other vasodilator drugs such as nitric oxide and calcium channel blockers
Normal semen analysis
Poor ovarian response</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients with other endocrine disorders such as hyperprolactinemia, PCOS, etc.
History of ovarian surgery or ovarian endometrioma
Smoker
Cardiovascular disorders
Unwillingness to cooperate
Sildenafil sensitivity and intolerance to side effects (hot flashes, vision disorders, severe drop in blood pressure and hearing disorders)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility of other origin</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: Sildenafil (sildenafil citrate 25 mg daily; Visarsin) starting from the first day of the cycle until the day of egg retrieval) along with Inofolic (Inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days</i_keyword>
      <i_keyword>Intervention group B: Melatonin (3 mg melatonin tablets daily; Razak Pharmaceutical Company, Iran) starting from the first day of the cycle until the day of egg retrieval along with inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days</i_keyword>
      <i_keyword>Intervention group C: Melatonin (daily 3 mg of melatonin tablets (Razak Pharmaceutical Company, Iran), starting from the first day of the cycle until the day of egg retrieval with sildenafil (daily 25 mg of sildenafil citrate; Visarsin) starting from the first day of the cycle until the day of egg retrieval with inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days</i_keyword>
      <i_keyword>Control group: Inofolic (inofolic powder 4 grams daily) starting from the first day of the previous cycle for 40 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oocyte Quality. Timepoint: 2-3 hrs. after oocyte collection. Method of measurement: Microscopic Evaluation.</prim_outcome>
      <prim_outcome>Number of retried oocyte. Timepoint: On day of oocyte retrieval. Method of measurement: Counting number of total oocytes with microscope.</prim_outcome>
      <prim_outcome>Number of embryo. Timepoint: On the 2nd day after ICSI. Method of measurement: Observation with microscope.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-07</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan Bandarabbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
