<?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>IRCT20090526001952N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-17</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assessment of pregnancy rate by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of infertility treatment success by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures referred to infertility clinic of Arash women hospital: a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1541</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 on the basis of a block randomization list which is designed by an epidemiologist colleague using the Stata software (LLC StataCorp, USA) version 13 and a block size of 6. The random allocation process is concealed by providing 34 consecutive treatment cards that is placed in sealed envelopes. A random 10-digit code is written without sequence and frame on each envelope. This relevant code is patient’s identification number, and just the project methodologist has known that this code is related to which treatment group. When the doctor announces that a patient is eligible, the methodologist has provided the doctor with an envelope design and the desired treatment is selected based on the type mentioned in the envelope. The outcome’s evaluator also is considered of a third party person who is unaware of the type of treatment performed. The data analysis is performed by a statistician who is unaware of all the study‘s processes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Laparoscopic ovarian drilling is performed using 40-watt bipolar current at 4-6 points of the ovaries for patients and a month later undergo in vitro fertilization (IVF) cycle with ovarian stimulation using an antagonist protocol. Intervention 2: Control group: In this group, patients without laparoscopic ovarian drilling are treated only for in-vitro fertilization (IVF) cycle with ovarian stimulation using antagonist protocol.</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 There is not a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sakineh Normohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash women's hospital, Reslat highway, Tehranpars, Rashid Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653915981</zip>
        <telephone>+98 21 7771 9922</telephone>
        <email>sakineh.nour@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Normohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash women's Hospital, Resalat highway, Tehranpars, Rashid Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653915981</zip>
        <telephone>+98 21 7771 9922</telephone>
        <email>sakineh.nour@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with poly cystic ovary syndrome who have two of the three diagnostic criteria Rotterdam at least
Age between 18- 35 year- old
Body mass index less than 30
Normal semen analysis in their spouse
Previous failed IVF procedures at least for 2 times
No laparoscopic contraindications</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>39 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Aged more than 39 year
Previous ovarian surgery
Co-existing endocrine diseases including diabetes mellitus, estrogen-dependent tumors, thyroid disease, Cushing’s syndrome, or congenital adrenal hyperplasia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility associated with anovulation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Laparoscopic ovarian drilling is performed using 40-watt bipolar current at 4-6 points of the ovaries for patients and a month later undergo in vitro fertilization (IVF) cycle with ovarian stimulation using an antagonist protocol.</i_keyword>
      <i_keyword>Control group: In this group, patients without laparoscopic ovarian drilling are treated only for in-vitro fertilization (IVF) cycle with ovarian stimulation using antagonist protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy rate. Timepoint: Beta-hCG test 14 days after embryo transfer. Method of measurement: Laboratory kits for Beta-hCG assay.</prim_outcome>
      <prim_outcome>Clinical pregnancy rate. Timepoint: 6 to 7 weeks after embryo transfer. Method of measurement: Observing the gestational sac along with fetal heart activity in vaginal ultrasound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Oocyte quality. Timepoint: Ovum pick-up day. Method of measurement: The number of Metaphase II oocytes obtained on the day of ovulation, which is reported by the embryologist.</sec_outcome>
      <sec_outcome>Abortion rate. Timepoint: before 20th week of pregnancy. Method of measurement: sonography.</sec_outcome>
      <sec_outcome>Embryo quality. Timepoint: before transfer. Method of measurement: It is determined by the embryologist based on the number of blastomeres and the percentage of fragmentation, multinucleation and symmetry on the third day after oocyte retrieval.</sec_outcome>
      <sec_outcome>Live birth rate. Timepoint: The delivery of a fetus who shows evidence of life after that is entirely outside of the mother. Method of measurement: Through hospital reports and telephone follow-up of patients.</sec_outcome>
      <sec_outcome>The pregnancy complications. Timepoint: during 9 months of pregnancy. Method of measurement: Complications such as premature delivery or premature rupture of the amniotic sac before 37 weeks of pregnancy and diagnosis of blood pressure above 140/90 (hypertension) along with edema and excretion of protein in the urine (Preeclampsia) as well as diagnosis of gestational diabetes (fasting plasma glucose equal to or greater than 92 mg/dL) with glucose 1 hour after consuming 75 grams of glucose equal to or more than 180 mg/dL) is recorded through checking the hospital report and telephone follow-up.</sec_outcome>
      <sec_outcome>Ovarian hyperstimulation syndrome rate. Timepoint: 3 and 10 days after ovarian puncture. Method of measurement: Examination of symptoms, signs of ovarian hyperstimulation (mild to moderate pain in the abdomen, bloating or increased waist size, nausea and vomiting, diarrhea, tenderness in the ovaries) and vaginal ultrasound.</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>2015-08-09</approval_date>
        <contact_name>Tehran University of Medical Sciences , Deputy of Research</contact_name>
        <contact_address>Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
