Anogenital Distance Differences Between Transgender Males and Female Individuals

NCT03789331 | Unknown

• 1 other identifier: UU-SUAM-2017-21/37
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Sexual Orientation Conflict Disorder

Keywords

transgender males; anogenital distance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Anti-Mullerian Hormone (AMH) level measurement

  8 hours

• FSH (Follicle-stimulating hormone), LH (Luteinizing hormone), Estradiol, and Testosteron level measurements

  8 hours

Study Arms (2)

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

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

Interventions

Anogenital distance measurement OTHER

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; Transgender Male individuals

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Ozluce, 16059, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Adnan Orhan, M.D.

  Uludag University, Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Central Study Contacts

Adnan Orhan, M.D.

CONTACT

+90 505 6337102; dr.adnan.orhan@hotmail.com

Ebru Sakar, M.D.

CONTACT

+90 507 8517109; ebru_sakar@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician and Gynecologist (M.D. and researcher)

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: April 1, 2019
• Primary Completion: February 15, 2020
• Study Completion: March 15, 2020
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

TU (1)