Anogenital Distance Differences Between Transgender Males and Female Individuals

Sexual Orientation Conflict Disorder Clinical Trial

Official title:

Anogenital Distance Differences Between Transgender Males and Female Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789331
• Other study ID #: UU-SUAM-2017-21/37
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2019
• Source: Uludag University
• Contact: Adnan Orhan, M.D.
• Phone: +90 505 6337102
• Email: dr.adnan.orhan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sexual Orientation Conflict Disorder

Intervention

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.

Locations

Country	Name	City	State
Turkey	Uludag University Hospital, Department of Obstetrics and Gynecology	Bursa	Ozluce

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Sánchez-Ferrer ML, Mendiola J, Hernández-Peñalver AI, Corbalán-Biyang S, Carmona-Barnosi A, Prieto-Sánchez 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anogenital Distance (Anus-Clitoris)	Anogenital Distance (Anus-Clitoris) will be measured from the anterior clitoral surface to the centre of the anus with a digital caliper in centimeters.	1 hour
Primary	Anogenital Distance (Anus-Posterior Fourchette)	Anogenital Distance (Anus-Posterior Fourchette) will be measured from the posterior fourchette to the centre of the anus with a digital caliper in centimeters.	1 hour
Secondary	Anti-Mullerian Hormone (AMH) level measurement	All blood samples will be collected in the morning after the patient has fasted for at least 8 hours.	8 hours
Secondary	FSH (Follicle-stimulating hormone), LH (Luteinizing hormone), Estradiol, and Testosteron level measurements	All blood samples will be collected in the morning after the patient has fasted for at least 8 hours.	8 hours