The goal of this observational study is to study the effects of treating women with Primary Ovarian Insufficiency (POI) with estrogen replacement therapy to bolster the evidence backing cardiometabolic preventive care in women with POI. The main question it aims to answer is:
Does 6 months of estrogen replacement therapy for women with POI improved markers of heart health?
Women newly diagnosed with POI (within 6 months) who are planning to start estrogen replacement therapy from their clinical provider will undergo assessment of markers of heart health before and after 6 months of treatment. These markers will also be compared to those obtained from healthy women without POI.
female sex
age 30-40
CASE PARTICIPANTS ONLY: clinically documented POI diagnosis within 6 months
CASE PARTICIPANTS ONLY: planning to clinically initiate 100mcg transdermal 17beta-estradiol twice weekly and micro-ionized progesterone (either 100mg daily or 200mg cyclically)
CASE PARTICIPANTS ONLY: genetic POI etiology
CASE PARTICIPANTS ONLY: any prior initiation of ERT
systemic estrogen, progesterone or testosterone therapy within the past 6 months (including contraception, except for locally acting intrauterine devices - IUDs)
lipid lowering therapy within the past 6 months
The study population is comprised of women newly diagnosed with POI (within 6 months) who are planning to clinically initiate hormonal replacement with 100mcg transdermal 17beta-estradiol twice weekly and micro-ionized progesterone (either 200mg cyclically or 100mg daily). For comparison, healthy women without POI matched 1:1 on age, BMI, and PREVENT™ risk score category (low-high risk) will also be studied.
Other
Prospective
Not listed
Brachial artery Flow Mediated Vasodilation (FMD)
Brachial artery flow-mediated dilation (FMD) is a non-invasive measure of endothelial function relevant to the development of incident cardiovascular disease. Brachial artery FMD will be reported as a percentage (%FMD), calculated by comparing the change in brachial artery diameter during reactive hyperemia to the baseline diameter. %FMD will be compared between case participants with POI and healthy control participants at baseline. The change in %FMD after 6 months of estrogen replacement therapy will be determined for case participants with POI.
Metabolic biomarkers
Urine and serum biomarkers relating to metabolism (including glucose and lipid metabolism, body composition)
Immune/inflammatory biomarkers
Urine and serum biomarkers relating to inflammation and immune activation
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