Study of Heart Electrical Activity in Women With Premature Ovarian Insufficiency and Effects of Estrogen-Progestin Therapy

What this Trial Is About

This research aims to understand how premature ovarian insufficiency POI, a condition affecting women under 40 and characterized by hormonal imbalances, impacts the hearts electrical activity, specifically the QT interval on an ECG. The study focuses on how sex hormones like estradiol and progesterone influence this interval and whether hormone replacement therapy HRT used in POI patients affects ventricular repolarization, potentially increasing the risk of dangerous heart rhythms. Researchers are investigating if women with POI are at higher risk for prolonged QTc, which can lead to sudden cardiac events. Participants include 60 women diagnosed with POI and 60 healthy women matched by age and body mass index. The study observes the effects of hormone replacement therapy, combining estrogen and progestin, on QTc duration. Measurements of QTc are taken before and after HRT introduction and during specific phases of the menstrual cycle, especially the luteal phase. The study is non-randomized and involves diagnostic ECG testing to monitor ventricular repolarization. During the trial, participants undergo ECG assessments to measure QTc intervals at various time points. The primary outcome is the QTc duration during the luteal phase between days 22 and 25 of the menstrual cycle. Secondary measurements include QTc duration before and up to 60 days after starting HRT. Participants medical histories, hormone levels, and treatment adherence are monitored. Safety considerations include excluding women with cardiac disorders, diabetes, or treatments that may affect QTc. The total duration of participation varies with hormone therapy and scheduled evaluations.

Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)