<?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>IRCT20200804048303N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-01</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The efficacy of Double Ovarian Stimulation for enhancing oocyte yield in assisted reproductive technology in patients with poor ovarian response</public_title>
      <acronym>Duostim</acronym>
      <scientific_title>Compare the efficacy of two methods of  Double Ovarian Stimulation for enhancing oocyte yield in assisted reproductive technology in patients with poor ovarian response</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52546</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: prospective interventional before  and after study.</study_design>
      <phase>2</phase>
      <hc_freetext>POOR OVERIAN RESPONSE.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  In group A, first a course of contraceptive pills was given to patients and then on the first to third day of mensturation ultrasound was done and cinnafact was administered at a dose of 50 units for three days and on the third day Pergoverisis administered twice daily and only Pergoveris continued. Ultrasound is performed on the fifth day of ovulation stimulation to examine the size of the grown follicles. When one or two follicles reach a size of 18 mm, triggering was done with decapeptyl 0/2 Mg administered simultaneously with 10,000 units HCGa way that three to five days after the initial ovulation, the patient was given two ampoules of Pergoveris again when the size of the follicle reached 18 mm. Triggering was done by decaptil 0/2 mg and HCG 10000 units. Intervention 2: Intervention group: In group B, after a course of contraceptive pills, on the first to third day of mensturation ultrasound was done, then letrozol 2/5 mg twice a day orally for five days from third day of menstration was started for patients wih injection of one pergoveris per day in 6th and 7th cycle- days. Follicular size was fallowed with transvaginal sonography When leading follicle was reached to 18mm 10,000 units HCG + 0/2 mg decapeptile was given intramuscularly. Then compared the results of the study between the two groups, including the number of oocytes recovered, the number of blastocysts found in the biopsy, the number of embryos transferred and the number of cases of successful clinical fertility.In the luteal phase, the GnRH antagonist will be considered.In such a way that three to five days after the initial ovulation, the patient was given two ampoules of Pergoveris again when the size of the follicle reached 18 mm. Triggering was done by decaptil 0/2 mg and HCG 10000 units.Then compared the results of the study between the two groups, including the number of oocytes recovered, the number of blastocysts found in the biopsy, the number of embryos transferred and the number of cases of successful clinical fertility.</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, only part of the information about the main outcome can be shared.

When:
6month after published article.

To whom:
Researchers work at university and research parts.

Conditions:
Analysis for scientific progression and improve treatment.

Where to obtain:
Demand by e.mail to: S.sheibani.pgrc@gmail.com or refer to Taleghani Hospital IVF and Infertility ward.

How to obtain:
We can e.mail data for at least one weak delay.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Sheibani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University, Shahid Arabi Ave, Yaman Ave, Shahid Chamran Ave, Teh, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2303 1111</telephone>
        <email>Taleghanihospital@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Sheibani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital , Shahid Arabi Ave , Yaman Ave, Shahid Chamran Highway , Teh , Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2303 1111</telephone>
        <email>TaleghaniHospital@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>Poor ovarian stimulation based on Poseidon group 3 criteria, AMH less than 1.2 ng / ml, antral follicle count less than 5 and age less than 35 years Group 4 poseidon includes older age equal to 35 years and AMH less than 1.2 ng/ml and the number of antral follicles less than 5 follicles
Group 4 poseidon includes older age equal to 35 years and AMH less than 1.2 ng/ml and the number of antral follicles less than 5 follicles</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with normal or excessive ovarian response
Women with excessive ovarian response</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ovarian dysfunction, 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 group:  In group A, first a course of contraceptive pills was given to patients and then on the first to third day of mensturation ultrasound was done and cinnafact was administered at a dose of 50 units for three days and on the third day Pergoverisis administered twice daily and only Pergoveris continued. Ultrasound is performed on the fifth day of ovulation stimulation to examine the size of the grown follicles. When one or two follicles reach a size of 18 mm, triggering was done with decapeptyl 0/2 Mg administered simultaneously with 10,000 units HCGa way that three to five days after the initial ovulation, the patient was given two ampoules of Pergoveris again when the size of the follicle reached 18 mm. Triggering was done by decaptil 0/2 mg and HCG 10000 units.</i_keyword>
      <i_keyword>Intervention group: In group B, after a course of contraceptive pills, on the first to third day of mensturation ultrasound was done, then letrozol 2/5 mg twice a day orally for five days from third day of menstration was started for patients wih injection of one pergoveris per day in 6th and 7th cycle- days. Follicular size was fallowed with transvaginal sonography When leading follicle was reached to 18mm 10,000 units HCG + 0/2 mg decapeptile was given intramuscularly. Then compared the results of the study between the two groups, including the number of oocytes recovered, the number of blastocysts found in the biopsy, the number of embryos transferred and the number of cases of successful clinical fertility.In the luteal phase, the GnRH antagonist will be considered.In such a way that three to five days after the initial ovulation, the patient was given two ampoules of Pergoveris again when the size of the follicle reached 18 mm. Triggering was done by decaptil 0/2 mg and HCG 10000 units.Then compared the results of the study between the two groups, including the number of oocytes recovered, the number of blastocysts found in the biopsy, the number of embryos transferred and the number of cases of successful clinical fertility.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of oocytes. Timepoint: Compare the number of oocytes and MII oocytes after induction ovulation in the follicular and luteal phase and two methods flare stimulation and minimal stimulation,. Method of measurement: Ultrasonography and puncture of oocytes and evaluate the presence of a polar body.</prim_outcome>
      <prim_outcome>Number of embryos. Timepoint: Number of embryos  after induction ovulation and oocyte retrieval in follicular and luteal phase and compare two methods of flare stimulation and minimal stimulation. Method of measurement: Inspection of embryos under the microscope.</prim_outcome>
      <prim_outcome>Number of blastocysts. Timepoint: The number of blastocysts after oocyte retrieval in the follicular and luteal phases and compare the two methods of flare stimulation and minimal stimulation. Method of measurement: Inspection of embryos under the microscope 5days after oocyte retrieval.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 4-6 weeks after embryo transfer(ET). Method of measurement: Transvaginal  ultrasonography and observe existence of gestational sac and fetal heart rate.</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>2021-01-31</approval_date>
        <contact_name>Preventative Gynecological Research Center</contact_name>
        <contact_address>Taleqani Hospital , Shahid Arabi Ave, Yaman Ave, Shahid Chamran 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>
