<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/NCT02993588</url>
  </required_header>
  <id_info>
    <org_study_id>Melatonin RCT</org_study_id>
    <nct_id>NCT02993588</nct_id>
  </id_info>
  <brief_title>Impact of Melatonin on IVF/ICSI Outcomes in Prospective Poor Responders</brief_title>
  <official_title>Impact of Melatonin Adjuvant Therapy on IVF/ICSI Outcomes in Prospective Poor Responders: A Double-blind, Randomized, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the impact of melatonin administration on in&#xD;
      vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes&#xD;
      and embryos in the prospective poor responders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prospective poor responders have been associated with lower number and poorer oocyte&#xD;
      quality. Melatonin is suggested to have antioxidative effects which may contribute to&#xD;
      improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes.&#xD;
      However, the expected beneficial effects of melatonin have not yet been investigated. The&#xD;
      purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI&#xD;
      outcomes namely the total number and quality of the oocytes and embryos in the prospective&#xD;
      poor responders. A randomized, double-blinded, placebo-controlled study is used to&#xD;
      investigate the impact of melatonin on the IVF/ICSI outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total number of retrieved mature oocytes</measure>
    <time_frame>On the day of oocyte retrieval procedure</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>In Vitro Fertilization</condition>
  <condition>Poor Ovarian Response</condition>
  <arm_group>
    <arm_group_label>Melatonin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Melatonin 6 mg tablet once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablet once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin</intervention_name>
    <description>Melatonin 6 mg tablet once daily</description>
    <arm_group_label>Melatonin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>one tablet once daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prospective poor responder with AMH &lt; 1 ng/ml and AFC &lt; 8 (in both ovaries).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe male factor infertility.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Osama Abdalmageed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women health center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Osama Abdalmageed, MD</last_name>
    <phone>1007972027</phone>
    <email>drosamast1981@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Osama Abdalmageed, MD</last_name>
    <phone>882102204</phone>
    <email>drosamast1981@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Osama Abdalmageed</name>
      <address>
        <city>Assiut</city>
        <state>Non-US/Non-Canadian</state>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Osama Abdalmageed, MD</last_name>
      <phone>1007972027</phone>
      <email>drosamast1981@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Osama Abdalmageed</last_name>
      <phone>1007972027</phone>
      <email>drosamast1981@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Osama Abdalmageed</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Osama Abdalmageed</last_name>
      <phone>1007972027</phone>
      <email>drosamast@yahoo.com.au</email>
    </contact>
    <contact_backup>
      <last_name>Osama Abdalmageed</last_name>
      <phone>1007972027</phone>
      <phone_ext>Abdalmageed</phone_ext>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Fernando S, Rombauts L. Melatonin: shedding light on infertility?--A review of the recent literature. J Ovarian Res. 2014 Oct 21;7:98. doi: 10.1186/s13048-014-0098-y.</citation>
    <PMID>25330986</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Osama Saber Thabet Abdalmageed</investigator_full_name>
    <investigator_title>Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity</investigator_title>
  </responsible_party>
  <keyword>Melatonin</keyword>
  <keyword>IVF/ICSI</keyword>
  <keyword>Poor ovarian response</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data will be kept with the study team only and it is not allowed by our institution regulations to share the data.</ipd_description>
  </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/NCT02993588
org study id: Melatonin RCT
nct id: NCT02993588
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the impact of melatonin administration on in
      vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes
      and embryos in the prospective poor responders.
The prospective poor responders have been associated with lower number and poorer oocyte
      quality. Melatonin is suggested to have antioxidative effects which may contribute to
      improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes.
      However, the expected beneficial effects of melatonin have not yet been investigated. The
      purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI
      outcomes namely the total number and quality of the oocytes and embryos in the prospective
      poor responders. A randomized, double-blinded, placebo-controlled study is used to
      investigate the impact of melatonin on the IVF/ICSI outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Total number of retrieved mature oocytes
time frame: On the day of oocyte retrieval procedure
arm group label: Melatonin
arm group type: Experimental
description: Melatonin 6 mg tablet once daily.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablet once daily
intervention type: Drug
intervention name: Melatonin
description: Melatonin 6 mg tablet once daily
arm group label: Melatonin
intervention type: Other
intervention name: Placebo
description: one tablet once daily
arm group label: Placebo
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 42 Years
healthy volunteers: No
last name: Osama Abdalmageed, MD
role: Principal Investigator
affiliation: Women health center
last name: Osama Abdalmageed, MD
phone: 1007972027
email: drosamast1981@gmail.com
last name: Osama Abdalmageed, MD
phone: 882102204
email: drosamast1981@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
citation: Fernando S, Rombauts L. Melatonin: shedding light on infertility?--A review of the recent literature. J Ovarian Res. 2014 Oct 21;7:98. doi: 10.1186/s13048-014-0098-y.
PMID: 25330986
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Osama Saber Thabet Abdalmageed
investigator title: Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity
mesh term: Melatonin
sharing ipd: No
ipd description: The data will be kept with the study team only and it is not allowed by our institution regulations to share the data.