Effects of hormone replacement therapy on heart function in women with premature ovarian insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how hormone replacement therapy (HRT) affects ventricular repolarization in women diagnosed with premature ovarian insufficiency (POI). It focuses on measuring the corrected QT interval (QTc) on ECG, which can indicate the risk of serious heart arrhythmias. The research aims to understand the relationship between hormonal levels and QTc prolongation, particularly in women under 40 with POI. By comparing these patients to healthy controls, the study seeks to identify potential cardiovascular risks associated with HRT in this population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Bachelot
  Paris, France Recruiting
• Pitié Salpêtrière
  Paris, France Recruiting
• Hopital Haut Leveque
  Bordeaux, France Active not recruiting

Study contacts

• Principal investigator: Anne Bachelot, Pr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Anne Bissery, MD
• Email: anne.bissery@aphp.fr
• Phone: 1 42 16 24 32

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Autologous Hair Follicle Secretome + PRP for POI

  This pilot study tests whether a patient’s own hair follicle secretome combined with their own platelet-rich plasma can improve ovarian function in women with premature ovarian insufficiency.

  Recruiting Phase 2 Trio Fertility · Toronto, Ontario · NCT07916740

• Intravenous hUC-MSCs for POI: Safety, Tolerability and Early Efficacy

  We’re testing whether IV human umbilical cord mesenchymal stem cells can be safely given to women under 40 with premature ovarian insufficiency to see if it helps improve ovarian function.

  Recruiting Phase 1/2 Shenzhen Wingor Biotechnology Co., Ltd. · Beijing, Beijing Municipality · NCT07775391

• Human amniotic mesenchymal stem cell treatment for premature ovarian insufficiency

  This trial will test whether an intravenous infusion of human amniotic mesenchymal stem cells combined with standard hormone therapy can help women under 40 with premature ovarian insufficiency.

  Recruiting Phase 1/2 Changhai Hospital · Shanghai · NCT07115082

• Hormone replacement for adolescents with premature ovarian insufficiency

  This study will test estrogen patches plus progesterone in girls and young women aged 11–19 with premature ovarian insufficiency to see if hormone replacement improves bone density, metabolic markers, muscle strength, and cardiovascular health.

  Recruiting Phase 3 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06851754

• Using Platelet-rich Plasma to Improve Female Fertility

  This study is testing whether injections of platelet-rich plasma can help improve fertility in women dealing with issues like poor ovarian response and repeated implantation failure.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT06645379

• Using fat-derived cells to treat premature ovarian insufficiency

  This study is testing if using fat-derived cells can help improve pregnancy chances for women with premature ovarian insufficiency compared to standard IVF treatments.

  Recruiting Peking University Third Hospital · Beijing, Beijing Municipality · NCT06481969

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.