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Anogenital Distance Differences Between Transgender Males and Female Individuals

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ClinicalTrials.gov Identifier: NCT03789331
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Adnan Orhan, Uludag University

Brief Summary:
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).

Condition or disease Intervention/treatment
Sexual Orientation Conflict Disorder Other: Anogenital distance measurement

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Anogenital Distance Differences Between Transgender Males and Female Individuals
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Transgender Male individuals
  • 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.
Other: Anogenital distance measurement

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.


Normal healthy female individuals
  • Group Description: Healthy women with normal sexual orientation.
  • Intervention: (The same) Anogenital distance measurement with a digital caliper in centimeters in the lithotomy position.
Other: Anogenital distance measurement

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.





Primary Outcome Measures :
  1. Anogenital Distance (Anus-Clitoris) [ Time Frame: 1 hour ]
    Anogenital Distance (Anus-Clitoris) will be measured from the anterior clitoral surface to the centre of the anus with a digital caliper in centimeters.

  2. Anogenital Distance (Anus-Posterior Fourchette) [ Time Frame: 1 hour ]
    Anogenital Distance (Anus-Posterior Fourchette) will be measured from the posterior fourchette to the centre of the anus with a digital caliper in centimeters.


Secondary Outcome Measures :
  1. Anti-Mullerian Hormone (AMH) level measurement [ Time Frame: 8 hours ]
    All blood samples will be collected in the morning after the patient has fasted for at least 8 hours.

  2. FSH (Follicle-stimulating hormone), LH (Luteinizing hormone), Estradiol, and Testosteron level measurements [ Time Frame: 8 hours ]
    All blood samples will be collected in the morning after the patient has fasted for at least 8 hours.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be healthy transgender male individuals whose gender identity (Male) are different from their birth-assigned sex (Female). These individuals are healthy biologically female persons and want to change their gender to male status. In Turkey, if a woman wants to change her gender, she has to bring a lawsuit against the birth registration office to change her gender to male status. Medico-legal assessments then have to be made at a tertiary gynecological center through the court. The participants will be invited to the study at the time of medico-legal evaluation before the sex reassignment surgery.
Criteria

Inclusion Criteria:

  • Individuals who are 18-50 years old.
  • Healthy transgender male individuals whose gender identity (Male) are different from their birth-assigned sex (Female). The participants will be invited to the study at the time of medico-legal evaluation before the sex reassignment surgery.

Exclusion Criteria:

  • Individuals who are older than 50 (People older than 50 cannot change their gender legally in Turkey).
  • Other sexual orientation disorders. (Lesbian, Gay, Bisexual, Queer, Intersex, or Asexual persons)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789331


Contacts
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Contact: Adnan Orhan, M.D. +90 505 6337102 dr.adnan.orhan@hotmail.com
Contact: Ebru Sakar, M.D. +90 507 8517109 ebru_sakar@hotmail.com

Locations
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Turkey
Uludag University Hospital, Department of Obstetrics and Gynecology Recruiting
Bursa, Ozluce, Turkey, 16059
Contact: Adnan Orhan, M.D.    +90 505 6337102    dr.adnan.orhan@hotmail.com   
Contact: Ebru Sakar, M.D    +90 507 8517109    ebru_sakar@hotmail.com   
Sponsors and Collaborators
Uludag University
Investigators
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Study Director: Adnan Orhan, M.D. Uludag University, Department of Obstetrics and Gynecology

Publications:
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Responsible Party: Adnan Orhan, Obstetrician and Gynecologist (M.D. and researcher), Uludag University
ClinicalTrials.gov Identifier: NCT03789331     History of Changes
Other Study ID Numbers: UU-SUAM-2017-21/37
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be available within 9 months of study completion.
Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adnan Orhan, Uludag University:
transgender males
anogenital distance