<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/NCT02987075</url>
  </required_header>
  <id_info>
    <org_study_id>NCKH-08-2016</org_study_id>
    <nct_id>NCT02987075</nct_id>
  </id_info>
  <brief_title>A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium</brief_title>
  <official_title>A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vietnam National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vietnam National University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo&#xD;
      transfer at 66±2 hours after ICSI using single step culture medium&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective cohort study to compare the outcomes of transferring the early compacting and&#xD;
      the cleavage day 3 embryos.&#xD;
&#xD;
      All participants were treated with a gonadotropin-releasing antagonist protocol according to&#xD;
      local protocol. Recombinant follicle stimulating hormone was given for five days starting on&#xD;
      the second or third day of the menstrual cycle at a starting dose individualized for each&#xD;
      participant as follows: 150, 225 or 300 IU/day, respectively, in participants with&#xD;
      anti-Müllerian hormone levels of &lt;2.1 ng/mL, 0.7-2.1 ng/mL or &lt;0.7 ng/mL. This dosage could&#xD;
      then be titrated based on clinical judgement of the investigator. Follicular development was&#xD;
      monitored using ultrasound scanning and measurement of estradiol and progesterone levels,&#xD;
      starting on day five of stimulation; scanning and hormonal measurements were repeated every&#xD;
      two to three days, depending on follicle size. An antagonist was routinely used on day five&#xD;
      until the day of human chorionic gonadotropin administration. Criteria for administration of&#xD;
      recombinant human chorionic gonadotropin (5,000 IU) was the presence of at least two leading&#xD;
      follicles of 17 mm in diameter. Oocyte retrieval was performed 36 hours after recombinant&#xD;
      human chorionic gonadotropin administration.&#xD;
&#xD;
      Insemination was performed using intra-cytoplasmic sperm injection at three to four hours&#xD;
      after oocyte retrieval; only matured oocytes were inseminated. Fertilization check was&#xD;
      performed under inverted microscope at 16-18 hours after insemination. Embryo evaluation was&#xD;
      performed on day 3 at fixed time point after fertilization (66±2 hours) using the Istanbul&#xD;
      consensus. As a rule, two useful embryos are transferred in patients if having either early&#xD;
      compaction or still on cleavage stage.&#xD;
&#xD;
      Early compaction embryo transfer group: transfer of 2 utilizable compacting embryos.&#xD;
&#xD;
      Cleavage stage embryo transfer group: transfer of 2 utilizable non-compacting embryos have&#xD;
      7-9 cells with under 20% fragmentation.&#xD;
&#xD;
      Embryo transfer was performed using a soft catheter by a standard technique under ultrasound&#xD;
      guidance. Intensive luteal phase support was provided using progesterone gel and estradiol.&#xD;
      At least 18 days after OPU, a urinary pregnancy test is performed. If the pregnancy test is&#xD;
      positive, vaginal and/or abdominal ultrasonographic investigation is performed between 35 and&#xD;
      42 days (5 to 6 weeks) after ET to confirm a clinical pregnancy and at least 70 days (≥10&#xD;
      weeks) after ET to confirm an ongoing pregnancy.&#xD;
&#xD;
      Other clinical parameters will also be evaluated: serum hormone levels, fertilization rate,&#xD;
      number and quality of day 3 embryos, implantation rate, ectopic pregnancy rate and&#xD;
      miscarriage rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate, defined as the presence of a gestational sac under ultrasonography</measure>
    <time_frame>7 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate (number of gestational sacs on ultrasound at 7 weeks / total number of embryos transferred x 100).</measure>
    <time_frame>7 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ectopic pregnancy rate, defined as the ectopic nidation of a pregnancy, confirmed with sonography or laparoscopy</measure>
    <time_frame>7 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Miscarriage rate, defined as the loss of a pregnancy prior to 12 weeks gestation</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">430</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Early compaction embryo group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients have compacting embryos at 66±2 hours after ICSI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cleavage stage embryo group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients have non-compacting embryos with 7-9 cells, under 20% fragmentation. at 66±2 hours after ICSI</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Compacting embryo transferring</intervention_name>
    <description>transfer of 2 utilizable compacting embryos</description>
    <arm_group_label>Early compaction embryo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non- compacting embryo transferring</intervention_name>
    <description>transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.</description>
    <arm_group_label>Cleavage stage embryo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IVF treatment for infertility&#xD;
&#xD;
          -  Controlled ovarian hyperstimulation by GnRH antagonist protocol.&#xD;
&#xD;
          -  IVF cycles ≤2&#xD;
&#xD;
          -  Eligible for transfer of 2 embryos on day 3&#xD;
&#xD;
          -  Have at least 2 embryos which are 7-9 cells and fragmentation ≤20%, that had either&#xD;
             early compaction or still on cleavage stage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oocyte donation cycles&#xD;
&#xD;
          -  Abnormal uterine&#xD;
&#xD;
          -  Using GnRH agonist for triggering.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuong M Ho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CGRH - Vietnam National University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tuong M Ho, MD</last_name>
    <phone>+84 906633377</phone>
    <email>homanhtuong@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anh H Dang, Msc</last_name>
    <phone>+ 84 908 302412</phone>
    <email>anh.dh@myduchospital.vn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>My Duc Hospital</name>
      <address>
        <city>Ho Chi Minh City</city>
        <zip>70000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vinh Q Dang, MD</last_name>
      <phone>+84908225481</phone>
      <email>bsvinh.dq@myduchospital.vn</email>
    </contact>
    <contact_backup>
      <last_name>Bao G Huynh, MSc</last_name>
      <phone>+ 84 908609348</phone>
      <email>bao.hg@myduchospital.vn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>July 12, 2017</last_update_submitted>
  <last_update_submitted_qc>July 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vietnam National University</investigator_affiliation>
    <investigator_full_name>Manh Tuong Ho</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02987075
org study id: NCKH-08-2016
nct id: NCT02987075
lead sponsor: 
has dmc: No
A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo
      transfer at 66±2 hours after ICSI using single step culture medium
A prospective cohort study to compare the outcomes of transferring the early compacting and
      the cleavage day 3 embryos.

      All participants were treated with a gonadotropin-releasing antagonist protocol according to
      local protocol. Recombinant follicle stimulating hormone was given for five days starting on
      the second or third day of the menstrual cycle at a starting dose individualized for each
      participant as follows: 150, 225 or 300 IU/day, respectively, in participants with
      anti-Müllerian hormone levels of <2.1 ng/mL, 0.7-2.1 ng/mL or <0.7 ng/mL. This dosage could
      then be titrated based on clinical judgement of the investigator. Follicular development was
      monitored using ultrasound scanning and measurement of estradiol and progesterone levels,
      starting on day five of stimulation; scanning and hormonal measurements were repeated every
      two to three days, depending on follicle size. An antagonist was routinely used on day five
      until the day of human chorionic gonadotropin administration. Criteria for administration of
      recombinant human chorionic gonadotropin (5,000 IU) was the presence of at least two leading
      follicles of 17 mm in diameter. Oocyte retrieval was performed 36 hours after recombinant
      human chorionic gonadotropin administration.

      Insemination was performed using intra-cytoplasmic sperm injection at three to four hours
      after oocyte retrieval; only matured oocytes were inseminated. Fertilization check was
      performed under inverted microscope at 16-18 hours after insemination. Embryo evaluation was
      performed on day 3 at fixed time point after fertilization (66±2 hours) using the Istanbul
      consensus. As a rule, two useful embryos are transferred in patients if having either early
      compaction or still on cleavage stage.

      Early compaction embryo transfer group: transfer of 2 utilizable compacting embryos.

      Cleavage stage embryo transfer group: transfer of 2 utilizable non-compacting embryos have
      7-9 cells with under 20% fragmentation.

      Embryo transfer was performed using a soft catheter by a standard technique under ultrasound
      guidance. Intensive luteal phase support was provided using progesterone gel and estradiol.
      At least 18 days after OPU, a urinary pregnancy test is performed. If the pregnancy test is
      positive, vaginal and/or abdominal ultrasonographic investigation is performed between 35 and
      42 days (5 to 6 weeks) after ET to confirm a clinical pregnancy and at least 70 days (≥10
      weeks) after ET to confirm an ongoing pregnancy.

      Other clinical parameters will also be evaluated: serum hormone levels, fertilization rate,
      number and quality of day 3 embryos, implantation rate, ectopic pregnancy rate and
      miscarriage rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
time frame: 12 weeks
measure: Clinical pregnancy rate, defined as the presence of a gestational sac under ultrasonography
time frame: 7 weeks
measure: Implantation rate (number of gestational sacs on ultrasound at 7 weeks / total number of embryos transferred x 100).
time frame: 7 weeks
measure: Ectopic pregnancy rate, defined as the ectopic nidation of a pregnancy, confirmed with sonography or laparoscopy
time frame: 7 weeks
measure: Miscarriage rate, defined as the loss of a pregnancy prior to 12 weeks gestation
time frame: 12 weeks
arm group label: Early compaction embryo group
arm group type: Other
description: patients have compacting embryos at 66±2 hours after ICSI
arm group label: Cleavage stage embryo group
arm group type: Other
description: patients have non-compacting embryos with 7-9 cells, under 20% fragmentation. at 66±2 hours after ICSI
intervention type: Other
intervention name: Compacting embryo transferring
description: transfer of 2 utilizable compacting embryos
arm group label: Early compaction embryo group
intervention type: Other
intervention name: Non- compacting embryo transferring
description: transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.
arm group label: Cleavage stage embryo group
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tuong M Ho, MD
role: Principal Investigator
affiliation: CGRH - Vietnam National University
last name: Tuong M Ho, MD
phone: +84 906633377
email: homanhtuong@yahoo.com
last name: Anh H Dang, Msc
phone: + 84 908 302412
email: anh.dh@myduchospital.vn
facility: 
status: Recruiting
contact: 
contact backup: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Vietnam National University
investigator full name: Manh Tuong Ho
investigator title: Director
mesh term: Infertility
sharing ipd: No