Do people on testosterone for cross-sex hormone therapy need contraception? The testosterone and ovulation in trans men study (TOTS) study
Contraception
Awarded 2018
Complex Family Planning Fellowship Research
Rebecca Taub, MD
University of Washington
$99,492

Objective 1: Determine whether long-term testosterone therapy in female-to-male transgender individuals suppresses ovulation.
Hypothesis: Testosterone therapy does not reliably suppress ovulation in all trans men on testosterone. 
Objective 2: Describe differences in trans men who ovulate while on testosterone vs trans men who do not ovulate following initiation of testosterone therapy
Hypothesis: Trans men who are on testosterone and do not ovulate may be on therapy for a longer duration than those that do ovulate, or may maintain higher serum testosterone levels at mid-cycle measurements.  Trans men who do ovulate may demonstrate higher serum estradiol levels than those who do not ovulate.
Objective 3: Describe effect of initiating testosterone therapy on AMH levels.
Hypothesis: New initiators of testosterone will show a decrease in AMH levels over 3 months of testosterone therapy.
 Study Design:
This is a descriptive study of hormonal patterns and ovulation in female-to-male transgender individuals using testosterone therapy for gender dysphoria.  We will recruit a cohort of 20 trans men at a local community clinic.  The study will include daily urinary hormone assays for 3 months as well as monthly blood draws.  Urine will be tested for progesterone and estrogen metabolites, LH, FSH, and testosterone in order to assess for ovulatory patterns.  Mid-cycle serum testosterone levels will be drawn monthly in order to correlate testosterone levels with observed hormone patterns.  For new initiators of testosterone, we will also collect a baseline and 3-month AMH level.  We will collect baseline data from an initial participant survey and chart review, and will have participants fill out a bleeding diary. 
 Potential Impact:
No research thus far has looked at ovulatory patterns of trans men on testosterone.  Though we know that trans men have both intended and unintended pregnancies, data on how to counsel trans men on the need for contraception is lacking.  This study will provide valuable information on alterations in hormone function in trans men on testosterone so that providers may better counsel their patients on contraception and fertility.

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