Addition of progesterone to feminizing gender-affirming hormone therapy in transgender individuals for breast development: a randomized controlled trial.

BACKGROUND: Feminizing gender-affirming hormone therapy (GAHT) for transgender individuals traditionally includes estradiol and androgen deprivation. Research has demonstrated that breast size as a result of GAHT in transgender women is often limited. Therefore, transgender women often choose to undergo breast augmentation surgery. Progesterone is important for breast development in cisgender women during puberty. A potential role for progesterone in breast development in transgender women has not been investigated in a randomized controlled experimental set-up. The primary objective of this study is to explore the effects on breast volume of addition of oral progesterone to GAHT with estradiol in transgender women after vaginoplasty or orchiectomy. Secondary objectives include assessment of safety, satisfaction, mood, sleep and sexual pleasure. METHODS: This is a non-blinded, non-placebo, randomized controlled trial using a factorial design in adult transgender individuals assigned male sex at birth who have undergone GAHT for at least one year and underwent vaginoplasty or orchiectomy. The study design allows for rapid assessment of potential synergistic effects of various dose combinations of estradiol and progesterone on breast volume change: Ninety participants will be randomized into six groups of 15 subjects each, receiving either the baseline dose of estradiol, the baseline dose of estradiol and progesterone 200 mg daily, the baseline dose of estradiol and progesterone 400 mg daily, twice the baseline dose of estradiol, twice the baseline dose of estradiol and progesterone 200 mg daily or twice the baseline dose of estradiol and progesterone 400 mg daily, all for a duration of 12 months. The main study parameters include changes in breast volume as determined by 3D measurements. Participants will be followed-up with laboratory testing including serum progesterone concentrations as well as surveys for satisfaction, mood, sleep quality and sexual pleasure. DISCUSSION: This study will indicate whether progesterone is safe and of additional value with regard to breast volume change in transgender individuals receiving feminizing GAHT. The results of this study will be useful for innovation of feminizing GAHT. TRIAL REGISTRATION: WHO International Clinical Trials Registry Platform: EUCTR2020-001952-16-NL; date of registration: 12 December 2020 https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2020-001952-16-NL .

'The medical world is very good at cis people, but trans is a specialisation'. Experiences of transgender and non-binary people with accessing primary sexual and reproductive healthcare services in the Netherlands.

Transgender and non-binary (TNB) people are at increased risk of adverse sexual and reproductive health (SRH) outcomes compared to cisgender people. With this qualitative study, we investigated the experiences of TNB people with access to primary SRH care in the Netherlands. We conducted semi-structured, explorative interviews with fourteen TNB individuals. Data were analysed using thematic analysis. We identified three themes: 'navigating cisgender assumptions', 'depending on your healthcare provider' and 'access requires labour'. In primary SRH care, respondents felt that healthcare providers made incorrect assumptions about their care needs which required respondents to actively disclose their gender identity or medical history. However, some respondents felt disclosure also exposed them to clinical bias, or reduced them to a medical category 'transgender' that their healthcare providers perceived to require specialised knowledge. In this context, respondents felt the onus was on them to ensure their SRH care needs were met. Using the concept of trans erasure, we highlight how TNB people are put at risk of adverse SRH outcomes. Creating equitable care access requires not only that providers are educated on TNB health needs and their own cisnormativity, but also an ongoing, critical reflection on the use of gender- and sex-based categories in medicine.

Pleasure please! Sexual pleasure and influencing factors in transgender persons: An ENIGI follow-up study.

Background: While the importance of sexual pleasure for physical and mental health becomes increasingly evident, research on sexual pleasure in transgender persons is lacking. Recently, the first version of the Amsterdam Sexual Pleasure Index (ASPI Vol. 0.1) was validated in cisgender persons. This questionnaire aims to assess the tendency to experience sexual pleasure independent of gender, sexual orientation or anatomy. Aim: The aims of this study were threefold. First, to perform exploratory scale validation analyses of the ASPI in transgender persons. Secondly, to compare transgender sexual pleasure scores to reference data in cisgender persons. Finally, to identify factors that are associated with sexual pleasure. Methods: In a follow-up study conducted within the European Network for the Investigation of Gender Incongruence (ENIGI), online questionnaires were distributed to persons who had a first clinical contact at gender clinics in Amsterdam, Ghent or Hamburg four to six years earlier. Internal consistency of the ASPI was assessed by calculating McDonald's omega (ωt). ASPI scores were compared to scores from the cisgender population using a one sample t-test, and linear regressions were conducted to study associations with clinical characteristics, psychological wellbeing, body satisfaction and self-reported happiness. Results: In total, 325 persons filled out the ASPI. The ASPI showed excellent internal consistency (ωt, all: 0.97; transfeminine: 0.97, transmasculine: 0.97). Compared to data from cisgender persons, transgender participants had significantly lower total ASPI scores (i.e., lower sexual pleasure; transgender vs. cisgender, mean(SD): 4.13(0.94) vs. 4.71(0.61)). Lower age, current happiness and genital body satisfaction were associated with a higher tendency to experience sexual pleasure. Conclusion & discussion: The ASPI can be used to assess the tendency to experience sexual pleasure and associated factors in transgender persons. Future studies are needed to understand interplaying biopsychosocial factors that promote sexual pleasure and hence transgender sexual health and wellbeing.

Changes in Serum Testosterone and Adrenal Androgen Levels in Transgender Women With and Without Gonadectomy.

BACKGROUND: Initiating feminizing gender-affirming hormone therapy (GAHT) in transgender women causes a steep decline in serum testosterone. It is unknown if testosterone concentrations change further and whether adrenal androgen levels change during feminizing GAHT and after gonadectomy. This limits clinical decision making in transgender women with symptoms attributed to GAHT or gonadectomy. METHODS: Transgender women (n = 275) initiating estradiol and cyproterone acetate (CPA) were included at baseline, and had follow-up visits after 3 months, 12 months, and 2 to 4 years. During follow-up, 49.5% of transgender women underwent a gonadectomy. Total testosterone (TT), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEAS), and androstenedione (A4) were measured using liquid chromatography tandem mass spectrometry. RESULTS: After 3 months of GAHT, mean TT, calculated free testosterone (cFT), and A4 decreased by 18.4 nmol/L (95% CI, -19.4 to -17.4, P < 0.001 [ie, -97.1%]), 383 pmol/L (95% CI, -405 to -362, P < 0.001 [ie, -98.3%]), and 1.2 nmol/L (95% CI, -1.4 to -1.0, P < 0.001 [ie, -36.5%]), respectively, and remained stable thereafter. DHEA and DHEAS decreased by 7.4 nmol/L (95% CI, -9.7 to -5.1 [ie, -28.0%]) and 1.8 µmol/L (95% CI, -2.2 to -1.4 [ie, -20.1%]), respectively, after 1 year and did not change thereafter. After gonadectomy, CPA therapy is stopped, which induced no further change in TT, cFT, DHEA, DHEAS, and A4 compared with those who did not undergo gonadectomy. CONCLUSIONS: Our findings confirm that after an initial drop, testosterone levels in transgender women remain stable. Adrenal androgens decrease in the first year of CPA and estrogen supplementation and remain unchanged after gonadectomy. Androgens did not change after gonadectomy and cessation of CPA. Correlates with clinical symptoms remain to be elucidated.

Rubella seroprevalence in pregnant women living with and without HIV in Soweto, South Africa.

OBJECTIVES: Rubella infection during pregnancy may cause foetal death or congenital rubella syndrome. In South Africa, the national public immunization programme does not include rubella vaccination. The aim of this study was to evaluate rubella sero-epidemiology in pregnant South African women living with and without HIV. METHODS: Serum samples obtained from women living with HIV (n=552) and without HIV (n=552) were tested for rubella immunoglobulin G antibodies using an ELISA. The proportions of women with seronegative titres (<8IU/ml) and seropositive titres (≥11IU/ml), and geometric mean titres (GMT) were compared by age group and HIV status. RESULTS: The overall proportion of rubella seropositivity was 97.8%. The proportion of seropositive women increased with age group (18-25 years: 97.0%; 26-32 years: 97.7%; 33-40 years: 99.3%; p=0.047 after adjusting for HIV status). Similar proportions of women living with and without HIV were seropositive. CONCLUSIONS: Rubella immunity was high among South African pregnant women living with and without HIV in the absence of rubella vaccination in the public immunization programme. However, a lower percentage of younger women had seropositive titres, indicating the need for routine rubella vaccination after an increase in vaccine coverage rates.

Maternal and perinatal outcomes of asylum seekers and undocumented migrants in Europe: a systematic review.

BACKGROUND: Asylum seekers (AS) and undocumented migrants (UM) are at risk of adverse pregnancy outcomes due to adverse health determinants and compromised maternal healthcare access and service quality. Considering recent migratory patterns and the absence of a robust overview, a systematic review was conducted on maternal and perinatal outcomes in AS and UM in Europe. METHODS: Systematic literature searches were performed in MEDLINE and EMBASE (until 1 May 2017), complemented by a grey literature search (until 1 June 2017). Primary research articles reporting on any maternal or perinatal outcome, published between 2007 and 2017 in English/Dutch were eligible for inclusion. Review protocols were registered on Prospero: CRD42017062375 and CRD42017062477. Due to heterogeneity in study populations and outcomes, results were synthesized narratively. RESULTS: Of 4652 peer-reviewed articles and 145 grey literature sources screened, 11 were included from 4 European countries. Several studies reported adverse outcomes including higher maternal mortality (AS), severe acute maternal morbidity (AS), preterm birth (UM) and low birthweight (UM). Risk of bias was generally acceptable, although the limited number and quality of some studies preclude definite conclusions. CONCLUSION: Limited evidence is available on pregnancy outcomes in AS and UM in Europe. The adverse outcomes reported imply that removing barriers to high-quality maternal care should be a priority. More research focussing on migrant subpopulations, considering potential risk factors such as ethnicity and legal status, is needed to guide policy and optimize care.