Clinical trial NCT07007416: Impact of Supraphysiological Estradiol on ECG in IVF Patients
Official title: Impact of Supraphysiological Estradiol Levels on Cardiac Electrophysiological Parameters During IVF: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In Vitro Fertilization
Estradiol
Cardiac Electrophysiology
Electrocardiography (ECG)
Reproductive Endocrinology
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in QTc Interval Before and After Gonadotropin-Induced Estradiol Elevation
timeFrame: Approximately 8-12 days from baseline to post-treatment ECG
Secondary outcomes:
measure: Change in PR Interval Following Gonadotropin-Induced Estradiol Elevation
timeFrame: Approximately 8-12 days
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
affiliation: Konya City Hospital
name: Dilay Gök Korucu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: