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Completed

NCT Number: NCT07007416

Impact of Supraphysiological Estradiol on ECG in IVF Patients

This prospective observational study aimed to evaluate the effects of supraphysiological estradiol (E2) levels, induced by gonadotropin therapy during IVF, on cardiac electrophysiological parameters. Sixty-two women aged 18-40 undergoing IVF treatment at Konya City Hospital between December 2024 and January 2025 were included.

ECG recordings were performed twice: once before gonadotropin stimulation and again on the day of hCG administration, when peak E2 levels were expected. Routine blood tests and hormone levels were also evaluated. Patients with obesity, cardiovascular disease, chronic illness, or medication use were excluded.

After treatment, significant increases were observed in PR interval, J-Tpeak, QTc, and Tp-e values. E2 changes showed a moderate negative correlation with QTc and a low positive correlation with J-Tpeak.

The results suggest that elevated E2 levels during IVF may affect cardiac electrophysiology, highlighting the need for careful monitoring in women with cardiac risk factors.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged 18 to 40 years

Undergoing IVF treatment at Konya City Hospital between December 2024 and January 2025

No cardiac pathology based on cardiology consultation

Eligible for controlled ovarian stimulation using a short antagonist protocol

Provided informed consent

Exclusion criteria

  • Age under 18 or over 40 years

Baseline estradiol level > 50 ng/L on day 2 of menstrual cycle

Presence of any known chronic diseases (e.g., diabetes mellitus, hypertension, rheumatologic disorders, thyroid disorders)

Use of any medications other than those used for IVF

Current smoker or alcohol user

Family history of cardiac disease or sudden cardiac death

Personal history of myocardial infarction, angina, heart failure, or any structural heart disease

History of cardiac surgery or coronary intervention

Treatment and study plan

Primary outcomes

  1. Change in QTc Interval Before and After Gonadotropin-Induced Estradiol Elevation

    Time frame: Approximately 8-12 days from baseline to post-treatment ECG

    QTc interval will be measured via 12-lead electrocardiography (ECG) at two timepoints: (1) on menstrual cycle day 2-3 prior to gonadotropin stimulation (baseline), and (2) on the day of hCG administration when estradiol reaches peak levels. The difference between pre- and post-treatment QTc values will be calculated.

Secondary outcomes

  1. Change in PR Interval Following Gonadotropin-Induced Estradiol Elevation

    Time frame: Approximately 8-12 days

    PR interval will be assessed using standard 12-lead ECG both before and after gonadotropin stimulation. Measurements will be taken on menstrual day 2-3 and again on the day of hCG administration to evaluate PR interval prolongation in response to elevated estradiol levels.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Impact of Supraphysiological Estradiol Levels on Cardiac Electrophysiological Parameters During IVF: A Prospective Observational Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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