Summary

Eligibility
for females ages 18-35 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion
Principal Investigator
Jeffrey Chang, MD

Description

Summary

Significant proportions of TGM report desired child-bearing and many engage in receptive vaginal intercourse with cisgender men or transgender women. Despite the frequency of desired fertility among TGM, secondary amenorrhea and associated infertility are common in those undergoing treatment with testosterone. Although testosterone is the mainstay of gender affirming care in this population, the mechanism of androgen-induced menstrual suppression is unknown due to the limited quantity of well-designed, clinical research investigating hypothalamic-pituitary-ovarian function in testosterone-treated TGM. We hypothesize that gender affirming testosterone therapy causes infertility in transgender men through impaired gonadotropin secretion, altered ovarian function, or a combination of these effects. We therefore propose to study the effect of high-dose, exogenous androgen administration on pituitary function, ovarian folliculogenesis, and ovulatory function in transgender men. Please note that administration of testosterone cyprionate, at a dose of 50 mg (T50) per week, will be done at Planned Parenthood of the Pacific Southwest by Dr. Kyle Bukowski. Who is the Associate Medical Director. In the first of our studies, in order to determine whether normal feedback mechanisms responsible for induction of gonadotropin responses to circulating steroid hormones are altered in TGM on testosterone, we will transiently administer steroid hormones and measure resultant changes in gonadotropin secretion among TGM before and during testosterone therapy, and in untreated cisgender female control subjects. In the next study, to determine whether testosterone alters ovarian follicle function and steroidogenesis, we will assess granulosa cell production of estradiol in response to FSH stimulation in TGM before and during testosterone therapy.

Official Title

Gonadotropin and Steroid Hormone Secretion in Transgender Males

Details

Thirteen transgender men (TGM) and 13 cisgender female (CGF) control subjects with congruent female gender identity and sex will be enrolled in the following studies.

  1. Ovarian follicle responses to FSH stimulation All subjects in each study group will undergo assessment of follicle responsiveness to intravenous (i.v.) recombinant FSH (r-FSH) stimulation 150 IU based on our previously published studies. Prior to testosterone treatment in TGM, r-FSH stimulation will be performed in the early follicular phase (EFP) of the cycle to approximate basal serum estradiol levels observed in the testosterone-treated TGM. Blood samples will be obtained before, and at 12 and 24 hours following each i.v. r-FSH injection for measurements of gonadotropins and sex steroid hormones. Subsequent r-FSH stimulation will be conducted on a random day at three- and six- months after testosterone treatment as we expect testosterone-treated TGM to be anovulatory. Blood samples will be obtained before, and at 12 and 24 hours following each i.v. r-FSH injection for measurements of sex steroid hormones.

ii. Gonadotropin responses to steroid hormone feedback On the morning of study day 1 (t=0) of study each subject will have a blood sample drawn in the morning for baseline hormone determinations. Subsequently, an intramuscular (i.m.) injection of estradiol valerate, 5 mg, will be administered. On study day 2 (t=48 hr), each subject will be administered an i.m. injection of progesterone in oil, 50 mg. Blood samples will be obtained t=0, +24, +48, +60, and +72 hr for the assessment of gonadotropin and steroid hormone levels. Serum FSH and LH levels following steroid administration in TGM will be compared to those observed in untreated TGM and CGF.

All subjects in each study group will undergo the same intervention as described above. TGM subjects will be studied during the early follicular phase of the menstrual cycle before and after three and six months of testosterone therapy. Should amenorrhea occur during T50 therapy, then study will be performed on a random day within one week of the three- and six- month time points. Untreated CGF controls will be studied once during the early follicular phase of the menstrual cycle.

Keywords

Transgenderism Healthy Testosterone therapy Estradiol 3-benzoate Estradiol 17 beta-cypionate Hormones Estradiol Polyestradiol phosphate Progesterone Follicle Stimulating Hormone Recombinant follicle-stimulating hormone Estradiol Valerate Progesterone Injectable Provocative Hormonal Testing

Eligibility

You can join if…

Open to females ages 18-35

  • Cisgender Female or Transgender Male
  • Regular menstrual cycles
  • For self-identified transgender males, must plan to initiate testosterone therapy for the first time within 3 months of study enrollment

You CAN'T join if...

    1. Hemoglobin less than 11 gm/dl at screening evaluation
  • Untreated thyroid abnormalities
  • Current endocrine disease- including pituitary or adrenal disease, polycystic ovary syndrome, or androgen producing tumor
  • Current or recent pregnancy within two months of study enrollment
  • Current or recent breast feeding within two months of study enrollment
  • BMI > 35
  • Diabetes, or renal, liver, or heart disease
  • History of oophorectomy
  • History of radiation or surgery involving brain structures
  • Current hormonal medication use (including birth control pills and hormone replacement therapy)
  • History of prior testosterone therapy

Lead Scientist at UCSD

  • Jeffrey Chang, MD
    Recall Faculty, Ob/Gyn & Reproductive sciences. Authored (or co-authored) 5 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04321551
Phase
Phase 4
Study Type
Interventional
Last Updated