RecruitingNot Applicable

Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)

France120 participantsStarted 2021-04-14

Plain-language summary

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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients with POI * Patient aged 18 to 41 years * Patient with POI diagnostic criteria (FSH \>25UI/l twice at intervals of a few weeks) with amenorrhea * No hormone treatment interacting with the gonadotropic axis for at least one month before inclusion * Patient who has signed informed consent * Patient affiliated to a social security system Healthy volunteers (including POI control group) * Healthy women, aged 18 to 40 years, age-matched (+/- 5 years), and by BMI class (BMI\<18, 18-25, 25-30, 30-35, 35-40, \>40) compared to women with BPI * Women with regular cycles of 26 to 32 days * Women who has signed an informed consent form * Patient affiliated to a social security system Exclusion Criteria: Patients with POI * Patient on HRT during the 1st evaluation * Pregnant or breastfeeding woman * Treatment regimen known to lengthen QT or act on ventricular repolarization * Cardiac history in particular cardiac rhythm disorder * Diabetes * Patient on AME (unless derogation from affiliation), * Severe renal insufficiency (MDRD \<30ml/min/m²) Healthy volunteers (including POI control group) * Diabetes or any chronic disease (including cardiovascular and endocrine) * Pregnant or breastfeeding woman * Hormonal contraceptive treatment in progress or stopped less than 3 months ago * Chronic treatment affecting the duration of QTc * Woman under AME (unless affiliation derogation)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of QTc

Timeframe: in the luteal phase between Day22 and Day25

Trial details

NCT IDNCT04167033

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-13

Contact for this trial

Anne Bissery, MD

1 42 16 24 32 anne.bissery@aphp.fr

View on ClinicalTrials.gov More Premature Ovarian Insufficiency trials