Impact of Supraphysiological Estradiol on ECG in IVF Patients

NCT ID: NCT07007416

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Konya City Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dilay Gök Korucu

Assistant Prof. of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilay Gök Korucu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Konya City Hospital

Locations

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Konya City Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024/026

Identifier Type: -

Identifier Source: org_study_id

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