<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/NCT01678859</url>
  </required_header>
  <id_info>
    <org_study_id>MFC 1</org_study_id>
    <nct_id>NCT01678859</nct_id>
  </id_info>
  <brief_title>Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women (C-MIS Study)</brief_title>
  <acronym>C-MIS</acronym>
  <official_title>Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merrion Fertility Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College Dublin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Merrion Fertility Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infertility affects approximately one in six couples1. In approximately one third of cases,&#xD;
      there is no cause found as to why a couple are unable to conceive2. In order for natural&#xD;
      pregnancy to occur, sperm must pass through the cervix (neck of the womb) and swim to the&#xD;
      woman's Fallopian tubes so that fertilisation of one of the woman's eggs can occur. It is&#xD;
      known that mid-cycle mucus at the cervix is essential for sperm to gain access to the uterus&#xD;
      and tubes.&#xD;
&#xD;
      There is evidence that the composition of this mucus in women may affect fertility but this&#xD;
      area has not been studied well in recent years, partly because fertility treatments such as&#xD;
      IVF bypass the cervix.&#xD;
&#xD;
      Research in sheep and cows in UCD has shown interesting differences in the cervical mucus of&#xD;
      fertile and infertile animals. It appears that the mucus not only helps sperm to get to the&#xD;
      uterus but may also help the sperm to mature and be ready to fertilise an egg. This mucus may&#xD;
      also help prevent bacteria and infection reaching the womb.&#xD;
&#xD;
      In conjunction with colleagues in UCD, under the leadership of Professor S Carrington, the&#xD;
      investigators would like to investigate some of the properties of human cervical mucus.The&#xD;
      investigators propose to do this by taking samples of cervical mucus around the time of&#xD;
      ovulation and also approximately one week later in fertile women and sub-fertile women. Then&#xD;
      to monitor ovulation with an ultrasound scan (follicle tracking) of the woman's ovaries and&#xD;
      urinary ovulation kits and take blood for oestrogen, progesterone, LH and FSH levels.&#xD;
&#xD;
      The investigators wish to determine if there are differences between the mucus of these women&#xD;
      and how it may impact on sperm function and on fertility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate functional, biochemical and molecular properties of cervical&#xD;
      mucus at various times of the menstrual cycle in fertile and sub-fertile women. The&#xD;
      investigators would aim to also investigate the interaction of cervical mucus with sperm and&#xD;
      capacitation and to investigate the impact cervical surgery and differing diagnoses of&#xD;
      sub-fertility have on cervical mucus.&#xD;
&#xD;
      Study aims:&#xD;
&#xD;
        1. To determine the functional, biochemical and molecular properties of cervical mucus&#xD;
           through out the menstrual cycle in fertile women.&#xD;
&#xD;
        2. To determine if there is a difference in these properties of cervical mucus in fertile&#xD;
           and sub-fertile women.&#xD;
&#xD;
        3. To determine whether these properties are influenced by the sub-fertility diagnostic&#xD;
           group eg unexplained, endometriosis, tubal factor, sperm factor.&#xD;
&#xD;
        4. To examine the interaction between cervical mucus and sperm in women with normal&#xD;
           fertility and sub-fertility.&#xD;
&#xD;
        5. To examine the impact of cervical surgery on cervical mucus functional, biochemical and&#xD;
           molecular properties and sperm interaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</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>The ability of sperm to swim through cervical mucus</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Infertility</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      cervical mucus serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        gyanecological outpatient department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Fertile women&#xD;
&#xD;
               1. Age 18-42 years&#xD;
&#xD;
               2. Regular ovulatory menstrual cycle&#xD;
&#xD;
               3. Previous spontaneous pregnancy to term&#xD;
&#xD;
               4. No history of subfertility&#xD;
&#xD;
               5. No underlying medical condition or immunosuppression&#xD;
&#xD;
               6. No history of hormonal medication or pregnancy in past two months&#xD;
&#xD;
               7. Capable of giving informed consent to participate in study&#xD;
&#xD;
          2. Non fertile women a.Age 18-42 years b.Regular ovulatory menstrual cycle c.Difficulty&#xD;
             conceiving for greater than 12 months e.No underlying medical condition or&#xD;
             immunosuppression f.No history of hormonal medication in past two months g.Capable of&#xD;
             giving informed consent to participate in study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. hormonal medication&#xD;
&#xD;
          2. pregnancy&#xD;
&#xD;
          3. not capable of giving consent&#xD;
&#xD;
          4. age &lt;18 years or &gt; 42 years&#xD;
&#xD;
          5. underlying medical condition&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mary wingfield, MD, FRCOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>merrion fertility clinic/National Maternity Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>fiona m martyn, MB, MRCOG</last_name>
    <phone>00353-1-6635000</phone>
    <phone_ext>4058</phone_ext>
    <email>f_martyn@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mary wingfield, MD, FRCOG</last_name>
    <phone>00353-1-6635000</phone>
    <phone_ext>4003</phone_ext>
    <email>mbwingfield@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Merrion fertility clinic/national maternity hospital</name>
      <address>
        <city>Holles streetdublin 2, ireland</city>
        <state>Dublin 2</state>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>fiona m martyn, MB,MRCOG</last_name>
      <phone>00353-1-6635000</phone>
      <phone_ext>4058</phone_ext>
      <email>f_martyn@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>fiona m martyn, MB,MRCOG</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>September 5, 2013</last_update_submitted>
  <last_update_submitted_qc>September 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>infertility</keyword>
  <keyword>cervical</keyword>
  <keyword>mucus</keyword>
  <keyword>sperm</keyword>
  <keyword>interaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT01678859
org study id: MFC 1
nct id: NCT01678859
lead sponsor: 
collaborator: 
has dmc: No
Infertility affects approximately one in six couples1. In approximately one third of cases,
      there is no cause found as to why a couple are unable to conceive2. In order for natural
      pregnancy to occur, sperm must pass through the cervix (neck of the womb) and swim to the
      woman's Fallopian tubes so that fertilisation of one of the woman's eggs can occur. It is
      known that mid-cycle mucus at the cervix is essential for sperm to gain access to the uterus
      and tubes.

      There is evidence that the composition of this mucus in women may affect fertility but this
      area has not been studied well in recent years, partly because fertility treatments such as
      IVF bypass the cervix.

      Research in sheep and cows in UCD has shown interesting differences in the cervical mucus of
      fertile and infertile animals. It appears that the mucus not only helps sperm to get to the
      uterus but may also help the sperm to mature and be ready to fertilise an egg. This mucus may
      also help prevent bacteria and infection reaching the womb.

      In conjunction with colleagues in UCD, under the leadership of Professor S Carrington, the
      investigators would like to investigate some of the properties of human cervical mucus.The
      investigators propose to do this by taking samples of cervical mucus around the time of
      ovulation and also approximately one week later in fertile women and sub-fertile women. Then
      to monitor ovulation with an ultrasound scan (follicle tracking) of the woman's ovaries and
      urinary ovulation kits and take blood for oestrogen, progesterone, LH and FSH levels.

      The investigators wish to determine if there are differences between the mucus of these women
      and how it may impact on sperm function and on fertility.
This study will investigate functional, biochemical and molecular properties of cervical
      mucus at various times of the menstrual cycle in fertile and sub-fertile women. The
      investigators would aim to also investigate the interaction of cervical mucus with sperm and
      capacitation and to investigate the impact cervical surgery and differing diagnoses of
      sub-fertility have on cervical mucus.

      Study aims:

        1. To determine the functional, biochemical and molecular properties of cervical mucus
           through out the menstrual cycle in fertile women.

        2. To determine if there is a difference in these properties of cervical mucus in fertile
           and sub-fertile women.

        3. To determine whether these properties are influenced by the sub-fertility diagnostic
           group eg unexplained, endometriosis, tubal factor, sperm factor.

        4. To examine the interaction between cervical mucus and sperm in women with normal
           fertility and sub-fertility.

        5. To examine the impact of cervical surgery on cervical mucus functional, biochemical and
           molecular properties and sperm interaction.
observational model: Case-Control
time perspective: Prospective
measure: The ability of sperm to swim through cervical mucus
time frame: 2 years
cervical mucus serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mary wingfield, MD, FRCOG
role: Principal Investigator
affiliation: merrion fertility clinic/National Maternity Hospital
last name: fiona m martyn, MB, MRCOG
phone: 00353-1-6635000
phone ext: 4058
email: f_martyn@yahoo.com
last name: mary wingfield, MD, FRCOG
phone: 00353-1-6635000
phone ext: 4003
email: mbwingfield@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Ireland
responsible party type: Sponsor
mesh term: Infertility