Sexual Orientation Conflict DisorderNCT03789331
Anogenital Distance Differences Between Transgender Males and Female Individuals
An observational study of Sexual Orientation Conflict Disorder, run by Uludag University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Orientation Conflict Disorder
- What is being tested?
- Anogenital distance measurement
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 15 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uludag University Hospital, Department of Obstetrics and Gynecology
Bursa, Ozluce, 16059
Adnan Orhan, M.D., +90 505 6337102, dr.adnan.orhan@hotmail.com
Ebru Sakar, M.D, +90 507 8517109, ebru_sakar@hotmail.com
About this study
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).
Read the 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.
- Conditions
- Sexual Orientation Conflict Disorder
- Being tested
- Anogenital distance measurement
- Keywords
- transgender males, anogenital distance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anogenital distance measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Anogenital distance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (2)
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.
Measured: 8 hours
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.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Apr 2019
- Primary completion15 Feb 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual Orientation Conflict DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Orhan, Uludag University
- Investigators
- Adnan Orhan, M.D., Study director, Uludag University, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789331
- Sponsor's protocol ID
- UU-SUAM-2017-21/37
- Status last verified
- Mar 2019
- First submitted
- 26 Dec 2018
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
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.
PubMed 28333243Sanchez-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.
PubMed 29025054
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anogenital Distance Differences Between Transgender Males and Female Individuals
- ClinicalTrials.gov ID
- NCT03789331
- Acronym / sponsor ID
- UU-SUAM-2017-21/37
- Conditions
- Sexual Orientation Conflict Disorder
- Keywords
- transgender males, anogenital distance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender Male individuals | – | Other: Anogenital distance measurement* 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. |
| Normal healthy female individuals | – | Other: Anogenital distance measurement* Group Description: Healthy women with normal sexual orientation. * Intervention: (The same) Anogenital distance measurement with a digital caliper in centimeters in the lithotomy position. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anogenital distance measurementThe 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. | Other | Normal healthy female individuals, Transgender Male individuals |
Primary outcome
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.
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.
2 secondary outcomes
Anti-Mullerian Hormone (AMH) level measurement
Time frame: 8 hours
FSH (Follicle-stimulating hormone), LH (Luteinizing hormone), Estradiol, and Testosteron level measurements
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Background: PubMed 28333243Wu 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.
- Background: PubMed 29025054Sanchez-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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Orhan, M.D. study director
Uludag University, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Orientation Conflict Disorder, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adnan Orhan, M.D. (+90 505 6337102, dr.adnan.orhan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anogenital Distance (Anus-Clitoris) (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03789331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.