<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/NCT03291860</url>
  </required_header>
  <id_info>
    <org_study_id>Antimullerian hormone</org_study_id>
    <nct_id>NCT03291860</nct_id>
  </id_info>
  <brief_title>Antimullerian Hormone as an Indicator for Ovarian Response</brief_title>
  <official_title>Antimullerian Hormone as an Indicator fo Ovarian Response in Women Receiving Long GnRH Agonist Protocol in Intracytoplasmic Sperm Injection Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anti Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility&#xD;
      assistance.&#xD;
&#xD;
      Investigators explored its correlation with oocytes retrieval after long GnRH agonist&#xD;
      protocol for stimulation, in younger and older infertile population. Methods: This&#xD;
      prospective analysis compiled data of 66 females, receiving ICSI treatment from April 2016 to&#xD;
      October 2017. Serum FSH, LH, Estadiol, AMH and antral follicle count were assessed. Outcomes&#xD;
      were measured as good (5 to 19 oocytes) and bad responders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 10, 2017</start_date>
  <completion_date type="Anticipated">October 10, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 10, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between AMH levels between good and poor responders in young patients receiving long GnRH agonist protocol for ICSI.</measure>
    <time_frame>1 month (1 cycle)</time_frame>
    <description>Measurement of AMH level in patients undergoing controlled ovarian stimulation prior to ICSI using long GnRH agonist protocol. Level will be compared between good and poor responders.</description>
  </primary_outcome>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Infertility, Female</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ovum retrievum</intervention_name>
    <description>assessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Sixty six women undergoing ICSI were enrolled in and a written informed consent was&#xD;
        obtained from each participant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age:20-40 years old&#xD;
&#xD;
          2. BMI:20-40kg/m&#xD;
&#xD;
          3. Normal baseline hormonal profile (on the 2nd day of the cycle)&#xD;
&#xD;
               -  FSH: 2.5-10.2mlU/ml&#xD;
&#xD;
               -  LH:1.9-12.5mlU/ml&#xD;
&#xD;
               -  Estradiol (E2): &lt;50pg/ml&#xD;
&#xD;
          4. No Endometriosis by laparoscopy&#xD;
&#xD;
          5. No prior ovarian surgery; overectomy, ovariectomy or oophrectomy&#xD;
&#xD;
          6. Female subjects who have at least 1 wash-out cycle (defined as greater than or equal&#xD;
             to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since&#xD;
             the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to&#xD;
             starting gonadotrophin releasing hormone (GnRH) agonist therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Age: &lt;20 or &gt;40 years old 2. BMI: &lt;20 or &gt;40kg/m 3. Female subjects with any&#xD;
             contraindication for pregnancy. 4. Female subjects with history of tumors of the&#xD;
             hypothalamus &amp; pituitary gland.&#xD;
&#xD;
             5. Female subjects with history of ovarian, uterine or mammary cancer. 6. Female&#xD;
             subjects with history of hypersensitivity to the active substance of the medications&#xD;
             used for ovarian stimulation.&#xD;
&#xD;
             7. Abnormal baseline hormonal profile 8. Endometriosis by laparoscopy 9. Previous&#xD;
             ovarian surgery; overectomy, ovariectomy or oophrectomy 10. Female subjects with&#xD;
             abnormal gynecological bleeding of unknown etiology&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed M Selim, MBBCh</last_name>
    <phone>00201123122003</phone>
    <email>dr.ahmedselim_89@yahoo.com</email>
  </overall_contact>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Mohammed Selim</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</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/NCT03291860
org study id: Antimullerian hormone
nct id: NCT03291860
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Anti Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility
      assistance.

      Investigators explored its correlation with oocytes retrieval after long GnRH agonist
      protocol for stimulation, in younger and older infertile population. Methods: This
      prospective analysis compiled data of 66 females, receiving ICSI treatment from April 2016 to
      October 2017. Serum FSH, LH, Estadiol, AMH and antral follicle count were assessed. Outcomes
      were measured as good (5 to 19 oocytes) and bad responders.
observational model: Cohort
time perspective: Prospective
measure: Difference between AMH levels between good and poor responders in young patients receiving long GnRH agonist protocol for ICSI.
time frame: 1 month (1 cycle)
description: Measurement of AMH level in patients undergoing controlled ovarian stimulation prior to ICSI using long GnRH agonist protocol. Level will be compared between good and poor responders.
intervention type: Procedure
intervention name: Ovum retrievum
description: assessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed M Selim, MBBCh
phone: 00201123122003
email: dr.ahmedselim_89@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: Ahmed Mohammed Selim
investigator title: Doctor
mesh term: Infertility
mesh term: Infertility, Female