Impact of Supraphysiological Estradiol on ECG in IVF Patients

NCT07007416 | Completed

• 1 other identifier: 2024/026
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

In Vitro Fertilization; Estradiol; Cardiac Electrophysiology; Electrocardiography (ECG); Reproductive Endocrinology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in PR Interval Following Gonadotropin-Induced Estradiol Elevation

  Approximately 8-12 days

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

Location

Study Officials

• Dilay Gök Korucu, M.D.

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof. of Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: December 15, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)