Impact of Supraphysiological Estradiol on ECG in IVF Patients

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

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.

Study Overview

• Status: Completed
• Conditions: In Vitro Fertilization; Cardiac Electrophysiology; Reproductive Endocrinology; Estradiol; Electrocardiography (ECG)

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42020
    • Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 to 40 years undergoing in vitro fertilization (IVF) treatment at the IVF Unit of Konya City Hospital. All participants were free of known cardiovascular or chronic systemic diseases and met the inclusion criteria for controlled ovarian stimulation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in QTc Interval Before and After Gonadotropin-Induced Estradiol Elevation	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.	Approximately 8-12 days from baseline to post-treatment ECG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PR Interval Following Gonadotropin-Induced Estradiol Elevation	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.	Approximately 8-12 days

Collaborators and Investigators

• Sponsor: Konya City Hospital
• Investigators: Principal Investigator: Dilay Gök Korucu, M.D., Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: May 28, 2025
• First Submitted That Met QC Criteria: May 28, 2025
• First Posted (Estimated): June 5, 2025

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024/026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No