<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/NCT03789331</url>
  </required_header>
  <id_info>
    <org_study_id>UU-SUAM-2017-21/37</org_study_id>
    <nct_id>NCT03789331</nct_id>
  </id_info>
  <brief_title>Anogenital Distance Differences Between Transgender Males and Female Individuals</brief_title>
  <official_title>Anogenital Distance Differences Between Transgender Males and Female Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uludag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uludag University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study evaluates the anogenital distance measurement differences between transgender male&#xD;
      individuals and normal healthy female individuals. Half of the participants will be selected&#xD;
      from the men with a masculine gender identity who were assigned female sex at birth (Woman&#xD;
      who wanted to be a man). Transgender men will be evaluated with the vaginal examination, and&#xD;
      anogenital distance will be measured at the time of gynecological medico-legal evaluation&#xD;
      before the sex reassignment surgery. While the other half of the participants will be&#xD;
      selected from healthy female individuals, ordinary healthy women will be selected from&#xD;
      patients who come to the gynecology clinic for another reason (Women with normal sexual&#xD;
      orientation).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is considerable evidence in human beings and in animal models supporting that&#xD;
      anogenital distance as a sensitive biomarker of prenatal androgen reflection of reproductive&#xD;
      health and sexual orientation. Anogenital distance is approximately twice as long in male&#xD;
      animals compared to female animals, and it is routinely used to determine the natal or&#xD;
      birth-assigned sex.&#xD;
&#xD;
      Studies have shown alterations in anogenital distance associated with reproductive health and&#xD;
      sexual orientation. For instance, shorter anogenital distance has been reported in boys with&#xD;
      hypospadias and cryptorchidism. Men with reduced testicular volume have significantly shorter&#xD;
      anogenital distance compared with controls. Increased anogenital distance has been indicated&#xD;
      in girls with congenital adrenal hyperplasia.&#xD;
&#xD;
      The investigators hypothesized that a prenatal pathological androgenic environment, resulting&#xD;
      in a longer anogenital distance, will be able to be associated with a higher risk of sexual&#xD;
      orientation disorders like transsexualism. This cross-sectional study aimed to assess the&#xD;
      anogenital distance measurement differences between transgender male persons and normal&#xD;
      healthy female individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">March 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anogenital Distance (Anus-Clitoris)</measure>
    <time_frame>1 hour</time_frame>
    <description>Anogenital Distance (Anus-Clitoris) will be measured from the anterior clitoral surface to the centre of the anus with a digital caliper in centimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anogenital Distance (Anus-Posterior Fourchette)</measure>
    <time_frame>1 hour</time_frame>
    <description>Anogenital Distance (Anus-Posterior Fourchette) will be measured from the posterior fourchette to the centre of the anus with a digital caliper in centimeters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-Mullerian Hormone (AMH) level measurement</measure>
    <time_frame>8 hours</time_frame>
    <description>All blood samples will be collected in the morning after the patient has fasted for at least 8 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FSH (Follicle-stimulating hormone), LH (Luteinizing hormone), Estradiol, and Testosteron level measurements</measure>
    <time_frame>8 hours</time_frame>
    <description>All blood samples will be collected in the morning after the patient has fasted for at least 8 hours.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Sexual Orientation Conflict Disorder</condition>
  <arm_group>
    <arm_group_label>Transgender Male individuals</arm_group_label>
    <description>Group Description: This group consists of transgender male individuals who come to the gynecology clinic for medico-legal evaluation before the sex reassignment surgery.&#xD;
Intervention: Anogenital distance measurement with a digital caliper in centimeters in the lithotomy position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal healthy female individuals</arm_group_label>
    <description>Group Description: Healthy women with normal sexual orientation.&#xD;
Intervention: (The same) Anogenital distance measurement with a digital caliper in centimeters in the lithotomy position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anogenital distance measurement</intervention_name>
    <description>The women were kindly asked to lay down in the lithotomy position with their thighs at 45° to the examination table. A digital caliper (Mitutoyo 500-752-10 ABSOLUTE Digimatic Coolant Proof Caliper 0-150mm / 0-6&quot;, Mitutoyo Corporation, Japan) was used to measure anogenital distance.&#xD;
Anogenital distance anus to clitoris: will be measured in centimeters from the anterior clitoral surface to the center of the anus.&#xD;
Anogenital distance anus to fourchette: will be measured in centimeters from the posterior fourchette to the center of the anus.&#xD;
Two investigators who were blind to the gynecological status of the women will measure each distance three times, and the mean value of the six measurements of each anogenital distance will be used.</description>
    <arm_group_label>Normal healthy female individuals</arm_group_label>
    <arm_group_label>Transgender Male individuals</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be healthy transgender male individuals whose gender identity&#xD;
        (Male) are different from their birth-assigned sex (Female). These individuals are healthy&#xD;
        biologically female persons and want to change their gender to male status. In Turkey, if a&#xD;
        woman wants to change her gender, she has to bring a lawsuit against the birth registration&#xD;
        office to change her gender to male status. Medico-legal assessments then have to be made&#xD;
        at a tertiary gynecological center through the court. The participants will be invited to&#xD;
        the study at the time of medico-legal evaluation before the sex reassignment surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who are 18-50 years old.&#xD;
&#xD;
          -  Healthy transgender male individuals whose gender identity (Male) are different from&#xD;
             their birth-assigned sex (Female). The participants will be invited to the study at&#xD;
             the time of medico-legal evaluation before the sex reassignment surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are older than 50 (People older than 50 cannot change their gender&#xD;
             legally in Turkey).&#xD;
&#xD;
          -  Other sexual orientation disorders. (Lesbian, Gay, Bisexual, Queer, Intersex, or&#xD;
             Asexual persons)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adnan Orhan, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Uludag University, Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adnan Orhan, M.D.</last_name>
    <phone>+90 505 6337102</phone>
    <email>dr.adnan.orhan@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ebru Sakar, M.D.</last_name>
    <phone>+90 507 8517109</phone>
    <email>ebru_sakar@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Uludag University Hospital, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Bursa</city>
        <state>Ozluce</state>
        <zip>16059</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adnan Orhan, M.D.</last_name>
      <phone>+90 505 6337102</phone>
      <email>dr.adnan.orhan@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ebru Sakar, M.D</last_name>
      <phone>+90 507 8517109</phone>
      <email>ebru_sakar@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Wu Y, Zhong G, Chen S, Zheng C, Liao D, Xie M. Polycystic ovary syndrome is associated with anogenital distance, a marker of prenatal androgen exposure. Hum Reprod. 2017 Apr 1;32(4):937-943. doi: 10.1093/humrep/dex042.</citation>
    <PMID>28333243</PMID>
  </reference>
  <reference>
    <citation>Sanchez-Ferrer ML, Mendiola J, Hernandez-Penalver AI, Corbalan-Biyang S, Carmona-Barnosi A, Prieto-Sanchez MT, Nieto A, Torres-Cantero AM. Presence of polycystic ovary syndrome is associated with longer anogenital distance in adult Mediterranean women. Hum Reprod. 2017 Nov 1;32(11):2315-2323. doi: 10.1093/humrep/dex274.</citation>
    <PMID>29025054</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>March 31, 2019</last_update_submitted>
  <last_update_submitted_qc>March 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uludag University</investigator_affiliation>
    <investigator_full_name>Adnan Orhan</investigator_full_name>
    <investigator_title>Obstetrician and Gynecologist (M.D. and researcher)</investigator_title>
  </responsible_party>
  <keyword>transgender males</keyword>
  <keyword>anogenital distance</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available within 9 months of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.</ipd_access_criteria>
  </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/NCT03789331
org study id: UU-SUAM-2017-21/37
nct id: NCT03789331
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the anogenital distance measurement differences between transgender male
      individuals and normal healthy female individuals. Half of the participants will be selected
      from the men with a masculine gender identity who were assigned female sex at birth (Woman
      who wanted to be a man). Transgender men will be evaluated with the vaginal examination, and
      anogenital distance will be measured at the time of gynecological medico-legal evaluation
      before the sex reassignment surgery. While the other half of the participants will be
      selected from healthy female individuals, ordinary healthy women will be selected from
      patients who come to the gynecology clinic for another reason (Women with normal sexual
      orientation).
There is considerable evidence in human beings and in animal models supporting that
      anogenital distance as a sensitive biomarker of prenatal androgen reflection of reproductive
      health and sexual orientation. Anogenital distance is approximately twice as long in male
      animals compared to female animals, and it is routinely used to determine the natal or
      birth-assigned sex.

      Studies have shown alterations in anogenital distance associated with reproductive health and
      sexual orientation. For instance, shorter anogenital distance has been reported in boys with
      hypospadias and cryptorchidism. Men with reduced testicular volume have significantly shorter
      anogenital distance compared with controls. Increased anogenital distance has been indicated
      in girls with congenital adrenal hyperplasia.

      The investigators hypothesized that a prenatal pathological androgenic environment, resulting
      in a longer anogenital distance, will be able to be associated with a higher risk of sexual
      orientation disorders like transsexualism. This cross-sectional study aimed to assess the
      anogenital distance measurement differences between transgender male persons and normal
      healthy female individuals.
observational model: Cohort
time perspective: Cross-Sectional
measure: Anogenital Distance (Anus-Clitoris)
time frame: 1 hour
description: Anogenital Distance (Anus-Clitoris) will be measured from the anterior clitoral surface to the centre of the anus with a digital caliper in centimeters.
measure: Anogenital Distance (Anus-Posterior Fourchette)
time frame: 1 hour
description: Anogenital Distance (Anus-Posterior Fourchette) will be measured from the posterior fourchette to the centre of the anus with a digital caliper in centimeters.
measure: Anti-Mullerian Hormone (AMH) level measurement
time frame: 8 hours
description: All blood samples will be collected in the morning after the patient has fasted for at least 8 hours.
measure: FSH (Follicle-stimulating hormone), LH (Luteinizing hormone), Estradiol, and Testosteron level measurements
time frame: 8 hours
description: All blood samples will be collected in the morning after the patient has fasted for at least 8 hours.
arm group label: Transgender Male individuals
description: Group Description: This group consists of transgender male individuals who come to the gynecology clinic for medico-legal evaluation before the sex reassignment surgery.
Intervention: Anogenital distance measurement with a digital caliper in centimeters in the lithotomy position.
arm group label: Normal healthy female individuals
description: Group Description: Healthy women with normal sexual orientation.
Intervention: (The same) Anogenital distance measurement with a digital caliper in centimeters in the lithotomy position.
intervention type: Other
intervention name: Anogenital distance measurement
description: The women were kindly asked to lay down in the lithotomy position with their thighs at 45° to the examination table. A digital caliper (Mitutoyo 500-752-10 ABSOLUTE Digimatic Coolant Proof Caliper 0-150mm / 0-6", Mitutoyo Corporation, Japan) was used to measure anogenital distance.
Anogenital distance anus to clitoris: will be measured in centimeters from the anterior clitoral surface to the center of the anus.
Anogenital distance anus to fourchette: will be measured in centimeters from the posterior fourchette to the center of the anus.
Two investigators who were blind to the gynecological status of the women will measure each distance three times, and the mean value of the six measurements of each anogenital distance will be used.
arm group label: Normal healthy female individuals
arm group label: Transgender Male individuals
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adnan Orhan, M.D.
role: Study Director
affiliation: Uludag University, Department of Obstetrics and Gynecology
last name: Adnan Orhan, M.D.
phone: +90 505 6337102
email: dr.adnan.orhan@hotmail.com
last name: Ebru Sakar, M.D.
phone: +90 507 8517109
email: ebru_sakar@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
citation: Wu Y, Zhong G, Chen S, Zheng C, Liao D, Xie M. Polycystic ovary syndrome is associated with anogenital distance, a marker of prenatal androgen exposure. Hum Reprod. 2017 Apr 1;32(4):937-943. doi: 10.1093/humrep/dex042.
PMID: 28333243
citation: Sanchez-Ferrer ML, Mendiola J, Hernandez-Penalver AI, Corbalan-Biyang S, Carmona-Barnosi A, Prieto-Sanchez MT, Nieto A, Torres-Cantero AM. Presence of polycystic ovary syndrome is associated with longer anogenital distance in adult Mediterranean women. Hum Reprod. 2017 Nov 1;32(11):2315-2323. doi: 10.1093/humrep/dex274.
PMID: 29025054
responsible party type: Principal Investigator
investigator affiliation: Uludag University
investigator full name: Adnan Orhan
investigator title: Obstetrician and Gynecologist (M.D. and researcher)
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available within 9 months of study completion.
ipd access criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.