Actively Recruiting
Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-09
120
Participants Needed
3
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ventricular repolarization, measured by corrected QT interval (QTc), is influenced by sex hormones. A QTc above 460msec predisposes to the risk of "torsades-de-pointes"(TdP). The investigators have recently shown that estradiol determines an increase in QTc elongation and progesterone shortens it. In addition, high gonadotropin levels (FSH or LH) are associated with QTc prolongation. Hypergonadotropic hypogonadisms (low progesterone and high gonadotropins) are therefore hormonal situations that promote QTc prolongation. Premature ovarian insufficiency (POI) is one of them. Its management is based on the prescription of hormone replacement therapy (HRT). Epidemiological studies have shown that these patients would be at increased risk of cardiovascular mortality. Our team is interested in the effect of this pathological hormonal situation and its HRT on ventricular repolarization in order to define whether this is a population at risk for long QTc.
CONDITIONS
Official Title
Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 41 years with premature ovarian insufficiency diagnosed by FSH >25 UI/l twice a few weeks apart and amenorrhea
- No hormone treatment affecting gonadotropins for at least one month before joining
- Signed informed consent
- Affiliated with a social security system
- Healthy female volunteers aged 18 to 40 years with regular menstrual cycles of 26 to 32 days
- Healthy volunteers matched by age (+/- 5 years) and BMI category compared to POI patients
- Signed informed consent
- Affiliated with a social security system
You will not qualify if you...
- Currently on hormone replacement therapy during first evaluation
- Pregnant or breastfeeding
- Taking treatments known to prolong QT or affect ventricular repolarization
- History of cardiac rhythm disorders
- Diabetes
- Receiving AME treatment unless affiliation exemption granted
- Severe kidney failure (MDRD <30 ml/min/m²)
- Chronic diseases including cardiovascular or endocrine conditions (for healthy volunteers)
- Hormonal contraceptive treatment ongoing or stopped less than 3 months ago (for healthy volunteers)
- Chronic treatment affecting QTc duration (for healthy volunteers)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Hopital Haut Leveque
Bordeaux, France
Active, Not Recruiting
2
BACHELOT
Paris, France, 75013
Actively Recruiting
3
Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
A
Anne Bissery, MD
CONTACT
F
Fredy Pene, Mr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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