The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection.
The main questions it aims to answer are:
Aim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy
Aim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone
Aim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone
Participants will be asked to:
* Get two pelvic ultrasounds * Fill out two surveys * Continue their current hormone replacement therapy * Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon)
Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups.
Age 12-25 years at baseline
Female assigned at birth, with uterus
Diagnosis of primary ovarian insufficiency or hypogonadotropic hypogonadism, requiring estrogen replacement therapy
Receiving estradiol therapy-oral (1-2mg) or transdermal (0.05-0.1mg)-for at least 3 months
Uterine abnormality (e.g., Müllerian Anomaly, uterine fibroids)
Inability to characterize the endometrial lining on ultrasound
History of chemotherapy or radiation therapy
Inability to complete study questionnaire
The study population includes 34 adolescent young adult individuals assigned female at birth, ages 12-25 years with a uterus in place, presenting to Children's Hospital Colorado-affiliated clinics: Pediatric and Adolescent Gynecology Clinic, Endocrine Clinic, Oncofertility Clinic, and Multidisciplinary Turner's Clinic.
Cohort
Prospective
Not listed
Mean change in endometrial thickness after 6 months of progesterone therapy
Measure the mean change and variability in endometrial thickness (mm) in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone via transabdominal pelvic ultrasound.
Measure the mean endometrial thickness on estrogen replacement therapy
Measure the mean endometrial thickness (mm) in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy via transabdominal pelvic ultrasound.
Satisfaction of progesterone replacement therapy
Assess overall satisfaction in AYA treated for 6 months with either the etonogestrel implant or continuous progesterone. This will be assessed via qualitative survey measures (10 point Likert scale).
Bleeding patterns on progesterone replacement therapy
Assess satisfaction with bleeding patterns in AYA treated for 6 months with either the etonogestrel implant or continuous progesterone. This will be assessed via qualitative survey measures (10 point Likert scale) and description of bleeding pattern (free response)
Side effects of progesterone replacement therapy
Assess side effects in AYA treated for 6 months with either the etonogestrel implant or continuous progesterone. This will be assessed via qualitative survey measures (free response).
Adherence to progesterone replacement therapy
Assess adherence in AYA treated for 6 months with either the etonogestrel implant or continuous progesterone. This will be assessed via qualitative survey in which participants will self report days of missed doses.
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