<?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>IRCT20210619051619N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-29</date_registration>
      <primary_sponsor>Royan Institute</primary_sponsor>
      <public_title>N-acetyl cysteine and endometrioma</public_title>
      <acronym></acronym>
      <scientific_title>Effect of N-acetyl cysteine on oxidative stress biochemical factors and IVF/ICSI outcomes in women with endometrioma: A randomized, double-blinded, phase III Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56973</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permuted blocks is method for random allocation. The size of the blocks varies, including 10 blocks and 4 blocks. The allocation ratio is equal in both groups. As soon as the included patient a unique identification code is assigned to the patient and will not change during the study, Blinding description: Participants, principle investigator, and healthcare providers do not have information about two study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Endometrioma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants who randomly assigned in the intervention group, during 6 weeks simultaneous to start standard long agonist protocol or antagonist  induction, will be received 1200 (2×600) mg of effervescent tablets of NAC daily. Blood will collect before the intervention and at the time of oocyte retrieval (end of 6 week), in addition to, follicular fluid will be obtained from the mature follicles. Also, we will measure severity of dysmenorea by visual analogue scale (VAS) technique. Intervention 2: Control group: Participants who randomly assigned to the control group, during 6 weeks simultaneous to start the standard long agonist protocol, or  antagonist induction, will be received 1200 (2×600) mg of placebo tablets of NAC daily. Blood will collect before the intervention and at the time of oocyte retrieval, in addition to, follicular fluid will be obtained from the mature follicles. Also, we measure severity of dysmenorrhea by visual analogue scale (VAS) technique.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvaneh Afsharin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Royan alley, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1665659911</zip>
        <telephone>+98 21 2356 2674</telephone>
        <email>p.afsharian@royan-rc.ac.ir</email>
        <affiliation>Royan Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvaneh Afsharian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Royan alley, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1665659911</zip>
        <telephone>+98 21 2356 2674</telephone>
        <email>p.afsharian@royan-rc.ac.ir</email>
        <affiliation>Royan Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 42 years old
Ultrasound or laparoscopic diagnosis of moderate to sever endometrioma (endometriosis stage III and IV)
Serum AMH levels  between 0.7 and 4.5 ng/ml
Standard long GnRH and antagonist ovulation stimulation cycle
Body mass index (BMI) &lt;30 kg/m2</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Non-inclusion criteria: Congenital uterine malformations
Severe male infertility (TESE, PESA)
Past medical history of asthma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis of ovary</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants who randomly assigned in the intervention group, during 6 weeks simultaneous to start standard long agonist protocol or antagonist  induction, will be received 1200 (2×600) mg of effervescent tablets of NAC daily. Blood will collect before the intervention and at the time of oocyte retrieval (end of 6 week), in addition to, follicular fluid will be obtained from the mature follicles. Also, we will measure severity of dysmenorea by visual analogue scale (VAS) technique.</i_keyword>
      <i_keyword>Control group: Participants who randomly assigned to the control group, during 6 weeks simultaneous to start the standard long agonist protocol, or  antagonist induction, will be received 1200 (2×600) mg of placebo tablets of NAC daily. Blood will collect before the intervention and at the time of oocyte retrieval, in addition to, follicular fluid will be obtained from the mature follicles. Also, we measure severity of dysmenorrhea by visual analogue scale (VAS) technique.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>MII oocyte number and quality. Timepoint: Immediately after oocyte puncture. Method of measurement: Observation of oocytes that were mature at the time of oocyte collection.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Measurement of TAC oxidative stress marker in blood plasma. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Measurement of SOD oxidative stress marker in blood plasma. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Measurement of TAC oxidative stress marker in folicular fluid. Timepoint: After oocyte puncture. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Measurement of SOD oxidative stress marker in folicular fluid. Timepoint: After oocyte puncture. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Cleaved embryo numbers. Timepoint: 2-3 days after oocyte puncture. Method of measurement: 2-3 days embryo  from fertilization.</sec_outcome>
      <sec_outcome>Blastocyst numbers. Timepoint: 5 days after oocyte puncture and sperm insemination. Method of measurement: The stage the embryo reaches after 5 days in culture from the egg retrieval.</sec_outcome>
      <sec_outcome>Clinical pregnancy rate. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG.</sec_outcome>
      <sec_outcome>Fertilization rate. Timepoint: 2-5 days after sperm insemination. Method of measurement: Percentage of transformation of micro injected oocytes into two pronuclei embryo.</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>Royan Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-16</approval_date>
        <contact_name>Ethics committee of Royan infertility institute</contact_name>
        <contact_address>Number 12, East Hafez Avenue, Bani Hashem Street, Soleimani Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
