The ENIGI (European Network for the Investigation of Gender Incongruence) Study: Overview of Acquired Endocrine Knowledge and Future Perspectives
Abstract
:1. Introduction
2. Description of the ENIGI Study
3. Materials and Methods
4. Overview of Acquired Knowledge
4.1. Body Modifications Induced by GAHT
4.1.1. Breast Development
4.1.2. Body Composition and Grip Strength
4.1.3. Dermatological Changes
4.1.4. Vaginal Bleeding
4.1.5. Voice
4.2. Safety of GAHT
4.2.1. Prolactin Levels
4.2.2. Erythrocytosis
4.2.3. Hepatic and Renal Safety
4.2.4. Lipid Profile
4.2.5. Insulin Sensitivity
4.2.6. Coagulation
4.2.7. Cardiovascular Safety
4.2.8. Bone Safety
4.2.9. Subjective Changes during GAHT
4.2.10. Emotional, Psychological, and Sexual Related Aspects
5. Future Perspectives and Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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AMAB (N = 1261) | AFAB (N = 1411) | Total (N = 2672) | |
---|---|---|---|
Study center (%) | |||
Amsterdam | 810 (64.2%) | 873 (61.9%) | 1683 |
Ghent | 345 (27.4%) | 296 (21.0%) | 641 |
Oslo | 30 (2.4%) | 141 (10%) | 171 |
Florence | 67 (5.3%) | 90 (6.3%) | 157 |
Tel Aviv | 9 (0.7%) | 11 (0.8%) | 20 |
Age (years) | 26.6 (22.0–38.8) | 22.3 (19.9–27.3) | 23.9 (20.6–32.4) |
Current smokers N (%) | 22.5% | 28.6% | 25.7% |
Weight (Kg) | 72.0 (63.5–83.5) | 67.0 (58.0–80.0) | 69.0 (60.1–82.0) |
Height (m) | 1.78 ± 0.07 | 1.67 ± 0.07 | 1.72 ± 0.09 |
BMI (Kg/m2) | 22.6 (20.1–25.9) | 23.7 (21.0–28.6) | 23.2 (20.6–27.1) |
Systolic blood pressure (mmHg) | 127.0 ± 15.0 | 120.0 ±13.0 | 123.0 ± 14.0 |
Diastolic blood pressure (mmHg) | 78.0 ± 10.0 | 75.0 ± 9.0 | 77.0 ± 10.0 |
Original Study Protocol | |
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Clinical evaluation | Height, weight, BMI, blood pressure, circumferences (waist, hip, chest, breast), grip strength, Norwood Hamilton scale for androgenetic alopecia, Ferriman Gallwey score for body and facial hair distribution, GAGS for acne activity. |
Laboratory measurements | 17-beta estradiol, testosterone, SHBG, LH, FSH, prolactin, IGF-1, blood count, calcium, vitamin D, albumin, TSH, alkaline phosphatase, gamma-GT, AST/ALT, triglycerides, total cholesterol, HDL-c, LDL-c, glucose, insulin, creatinine. |
Imaging | Dual-energy X-ray absorptiometry. |
Questionnaires | Sociodemographic and clinical information |
Baecke Activity Questionnaire This questionnaire allows the assessment of habitual physical activity. It consists of 16 questions classified into 3 different dimensions: work, sport, and non-sports leisure activity. Each domain can receive a score from 1 to 5 points, thus allowing a total score from 3 (minimum activity) to 15 (maximum activity). | |
Positive and Negative Affect Scale (PANAS) The PANAS is a 20-item questionnaire that measures long-term changes in affect. Participants are asked to what extent they experience certain feelings such as anxiety, happiness, or guilt on a 5-point scale from “very little” to “very much”. | |
State Anger Scale The State Anger scale is a 15-item questionnaire that evaluates aggression. Participants rank certain statements along a 4-point continuum from “not at all” to “very much”. The questionnaire evaluates angry feelings on 3 subscales: feeling angry, feeling like expressing anger verbally, and feeling like expressing anger physically. | |
Sexual Desire Inventory (SDI) SDI is a self-administered 14-item questionnaire that aims to measure sexual desire. The SDI measures the individual’s thoughts as well as actual experiences. Fourteen questions assess the strength, frequency, and importance of an individual’s desire for sexual activity with others and by themselves. The score ranges from 0 (no sexual desire) to 112 (maximum desire). | |
Sexual orientation questionnaire (SEXOR) This short questionnaire consists of 4 questions in the background data interview evaluating gender roles in sexual fantasy and sexual orientation. | |
Trans Voice Questionnaire The Trans Voice Questionnaire is a 30-item self-administered questionnaire that evaluates the psychosocial consequences of voice disorders and consists of 3 dimensions: functional, physical, and emotional impairment. A score of 0 is equivalent to no disability and a score of 120 is equivalent to maximum disability. | |
Side-effects questionnaire This questionnaire evaluates side-effects of hormonal treatment such as psychovegetative symptoms, physical complaints, cognition, emotionality and sexuality, genital complaints, and pain. | |
New study protocol | |
Clinical evaluation | Height, weight, BMI, blood pressure, heart rate, BIA. |
Laboratory measurements | 17-beta estradiol, testosterone, LH, blood count, AST/ALT, triglycerides, total cholesterol, HDL-c, LDL-c, glucose, creatinine. |
Questionnaires | Sociodemographic and clinical information |
Baecke Activity Questionnaire | |
Body Image Scale (BIS) The BIS questionnaire consists of 30 body characteristics. Respondents rate satisfaction with these body characteristics on a 5-point scale, ranging from 1 (very satisfied) to 5 (very dissatisfied). There are two sex-specific versions of the BIS—one for natal males and one for natal females—containing equivalent genital body parts. The scale includes primary sex characteristics, secondary sex characteristics, and non sex-related body parts. Higher scores represent higher degrees of body dissatisfaction. | |
Menstrual questionnaire This questionnaire evaluates presence and characteristics of menstrual cycle, in order to establish amenorrhea achievement with testosterone treatment in trans AFAB people. | |
Hormonal symptoms questionnaire This short questionnaire assesses the presence and intensity of several perceived symptoms, such as psychoneurovegetative symptoms, physical complaints, emotionality and sexuality complaints. | |
Fertility questionnaire This questionnaire contains several questions, in order to assess reproductive desire of transgender people. | |
Pittsburgh Sleep Quality Index (PSQI) PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a one-month time interval. Nineteen individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. | |
Insomnia Severity Index (ISI) ISI is composed of seven items evaluating: (a) the severity of sleep-onset (initial), (b) sleep maintenance (middle), (c) early morning awakening (terminal) problems, (d) satisfaction with current sleep pattern, (e) interference with daily functioning, (f) noticeability of impairment attributed to the sleep problem, and (g) level of distress caused by the sleep problem. Each of these items is rated on a five-point Likert scale (‘0’ = not at all, ‘4’ = extremely) and the time interval is in the last two weeks. Total scores range from 0 to 28, with high scores indicating greater insomnia severity. | |
Perceived stress scale (PSS) The PSS is an instrument used to measure stress, evaluating the perception of stressful experiences in the preceding month using a Likert-type five-point scale. PSS contains 14 items, seven of them positive and seven negative, and responses range from 0 to 4 (0 = never; 1 = almost never; 2 = sometimes; 3 = fairly often; 4 = very often). | |
Inventory of Depressive Symptomatology Self-Report scale This scale assess the presence and intensity of depressive symptoms. Items are scored on a four-point scale, with each item equally weighted and summed to a total score. A higher total score indicates more serious depression, with a maximum score of 84. | |
Difficulties in emotion regulation scale (DERS) DERS is a 36-item scale assessing difficulties in six regulatory abilities: lack of emotionalawareness, lack of emotional clarity, non-acceptance of emotional responses, difficulties engaging in goal-directed behavior, impulse control difficulties, and limited access to emotion regulation strategies. The scale is a Likert-type scale rated between 1 (almost never) and 5 (almost always) points, with higher scores indicating more regulation difficulties. |
AMAB | AFAB | |
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Biochemical monitoring |
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Cardiovascular safety |
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Bone safety |
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Emotional aspects and sexual health |
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Cocchetti, C.; Romani, A.; Collet, S.; Greenman, Y.; Schreiner, T.; Wiepjes, C.; den Heijer, M.; T’Sjoen, G.; Fisher, A.D. The ENIGI (European Network for the Investigation of Gender Incongruence) Study: Overview of Acquired Endocrine Knowledge and Future Perspectives. J. Clin. Med. 2022, 11, 1784. https://doi.org/10.3390/jcm11071784
Cocchetti C, Romani A, Collet S, Greenman Y, Schreiner T, Wiepjes C, den Heijer M, T’Sjoen G, Fisher AD. The ENIGI (European Network for the Investigation of Gender Incongruence) Study: Overview of Acquired Endocrine Knowledge and Future Perspectives. Journal of Clinical Medicine. 2022; 11(7):1784. https://doi.org/10.3390/jcm11071784
Chicago/Turabian StyleCocchetti, Carlotta, Alessia Romani, Sarah Collet, Yona Greenman, Thomas Schreiner, Chantal Wiepjes, Martin den Heijer, Guy T’Sjoen, and Alessandra Daphne Fisher. 2022. "The ENIGI (European Network for the Investigation of Gender Incongruence) Study: Overview of Acquired Endocrine Knowledge and Future Perspectives" Journal of Clinical Medicine 11, no. 7: 1784. https://doi.org/10.3390/jcm11071784
APA StyleCocchetti, C., Romani, A., Collet, S., Greenman, Y., Schreiner, T., Wiepjes, C., den Heijer, M., T’Sjoen, G., & Fisher, A. D. (2022). The ENIGI (European Network for the Investigation of Gender Incongruence) Study: Overview of Acquired Endocrine Knowledge and Future Perspectives. Journal of Clinical Medicine, 11(7), 1784. https://doi.org/10.3390/jcm11071784