<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03820167</url>
  </required_header>
  <id_info>
    <org_study_id>49</org_study_id>
    <nct_id>NCT03820167</nct_id>
  </id_info>
  <brief_title>Mitochondrial DNA in Fresh Versus Frozen Embryo Culture Media of PCOS Women Undergoing In Vitro Fertilization</brief_title>
  <official_title>Mitochondrial DNA in Fresh Versus Frozen Embryo Culture Media of Polycystic Ovarian Syndrome Patients Undergoing In Vitro Fertilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples&#xD;
      of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients&#xD;
      undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and&#xD;
      the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c&#xD;
      until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved&#xD;
      for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c&#xD;
      until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR&#xD;
      technique.The template DNA prepared and the dilution standards prepared will be used for qPCR&#xD;
      to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green&#xD;
      PCR Kit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples&#xD;
      of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients&#xD;
      undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and&#xD;
      the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c&#xD;
      until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved&#xD;
      for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c&#xD;
      until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR&#xD;
      technique.The template DNA prepared and the dilution standards prepared will be used for qPCR&#xD;
      to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green&#xD;
      PCR Kit (Qiagen)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">January 14, 2020</completion_date>
  <primary_completion_date type="Actual">December 25, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>4 weeks after embryo transfer</time_frame>
    <description>detection of intrauterine gestational sac by transvaginal ultrasound</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <condition>Assisted Reproduction</condition>
  <arm_group>
    <arm_group_label>Fresh sample</arm_group_label>
    <description>Morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested.&#xD;
Quantification of mtDNA in fresh and frozen culture media using qPCR technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Frozen embryos</arm_group_label>
    <description>Morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR technique.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      embryo culture media from day 3 morphologically good embryos will be collected after embryo&#xD;
      transfer of fresh and thawed cycles. The media will be immediately frozen into sterile, PCR&#xD;
      clean (free from DNA, DNase, RNase and PCR inhibitors) tubes and stored at - 20 C until&#xD;
      nucleic acid purification&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Detailed history taking with special emphasis on:&#xD;
&#xD;
          1. Personal history (name, age, marital state, parity, address).&#xD;
&#xD;
          2. Menstrual history (duration, cycle, amount, regularity, last menstrual period).&#xD;
&#xD;
          3. Medical history for acne and hirsutism.&#xD;
&#xD;
        Clinical examination with special emphasis on:&#xD;
&#xD;
          1. Height and weight of the patients to calculate the BMI (weight in kg/ height in m2).&#xD;
&#xD;
          2. Examinationfor presence of acne and/ or hirsutism (patients with score &gt; 8 on Ferryman&#xD;
             &amp; Gallawey score were considered as hirsute).&#xD;
&#xD;
          3. Ultrasound examination to confirm diagnosis of PCOS (Using the vaginal probe).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: 20-35 yrs.&#xD;
&#xD;
          2. BMI: ≤25.&#xD;
&#xD;
          3. PCO: diagnosed by Rotterdam criteria (at least two of the following):&#xD;
&#xD;
               1. Polycystic ovary morphology with one ovary being sufficient for diagnosis.&#xD;
&#xD;
               2. Hyperandrogenism: clinically or biochemically.&#xD;
&#xD;
               3. Anovulation or oligo-ovulation.&#xD;
&#xD;
          4. Gravidity and parity: Nulligravida.&#xD;
&#xD;
          5. Compliance: primary infertility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known medical problems as diabetes mellitus, hypertension, cardiac, hepatic or renal&#xD;
             problem.&#xD;
&#xD;
          -  Special habits of medical importance as smoking.&#xD;
&#xD;
          -  Other endocrinopathies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ganna IVF center</name>
      <address>
        <city>Giza</city>
        <state>Cairo</state>
        <zip>12111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed M Maged, MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03820167
org study id: 49
nct id: NCT03820167
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples
      of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients
      undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and
      the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c
      until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved
      for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c
      until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR
      technique.The template DNA prepared and the dilution standards prepared will be used for qPCR
      to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green
      PCR Kit
Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples
      of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients
      undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and
      the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c
      until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved
      for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c
      until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR
      technique.The template DNA prepared and the dilution standards prepared will be used for qPCR
      to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green
      PCR Kit (Qiagen)
observational model: Case-Control
time perspective: Prospective
measure: clinical pregnancy rate
time frame: 4 weeks after embryo transfer
description: detection of intrauterine gestational sac by transvaginal ultrasound
arm group label: Fresh sample
description: Morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested.
Quantification of mtDNA in fresh and frozen culture media using qPCR technique.
arm group label: Frozen embryos
description: Morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR technique.
embryo culture media from day 3 morphologically good embryos will be collected after embryo
      transfer of fresh and thawed cycles. The media will be immediately frozen into sterile, PCR
      clean (free from DNA, DNase, RNase and PCR inhibitors) tubes and stored at - 20 C until
      nucleic acid purification
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 38 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: Professor
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed M Maged, MD
investigator title: Principal investigator
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome