Anogenital Distance Differences Between Transgender Males and Female Individuals

NCT ID: NCT03789331

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-15

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Sexual Orientation Conflict Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Anogenital distance measurement

Intervention Type 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

* Group Description: Healthy women with normal sexual orientation.
* Intervention: (The same) Anogenital distance measurement with a digital caliper in centimeters in the lithotomy position.

Anogenital distance measurement

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Adnan Orhan

Obstetrician and Gynecologist (M.D. and researcher)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adnan Orhan, M.D.

Role: STUDY_DIRECTOR

Uludag University, Department of Obstetrics and Gynecology

Locations

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Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Ozluce, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Adnan Orhan, M.D.

Role: CONTACT

+90 505 6337102

Ebru Sakar, M.D.

Role: CONTACT

+90 507 8517109

Facility Contacts

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Adnan Orhan, M.D.

Role: primary

+90 505 6337102

Ebru Sakar, M.D

Role: backup

+90 507 8517109

References

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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.

Reference Type BACKGROUND
PMID: 28333243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29025054 (View on PubMed)

Other Identifiers

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UU-SUAM-2017-21/37

Identifier Type: -

Identifier Source: org_study_id

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