In Vitro FertilizationNCT07007416
Impact of Supraphysiological Estradiol on ECG in IVF Patients
An observational study of In Vitro Fertilization and Estradiol, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- In Vitro Fertilization, Estradiol, Cardiac Electrophysiology
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 8-12 days from baseline to post-treatment ECG
Secondary outcomes (1)
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.
Measured: Approximately 8-12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 Dec 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilay Gök Korucu, Konya City Hospital
- Investigators
- Dilay Gök Korucu, M.D., Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007416
- Sponsor's protocol ID
- 2024/026
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savas B, Korucu DG, Gok G. The Effects of Supraphysiological Estrogen Levels Observed During In Vitro Fertilization Treatment on Cardiac Electrophysiology. Ann Noninvasive Electrocardiol. 2026 Mar;31(2):e70160. doi: 10.1111/anec.70160.
PubMed 41719160
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Supraphysiological Estradiol Levels on Cardiac Electrophysiological Parameters During IVF: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07007416
- Acronym / sponsor ID
- 2024/026
- Conditions
- In Vitro Fertilization, Estradiol, Cardiac Electrophysiology, Electrocardiography (ECG), Reproductive Endocrinology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Change in PR Interval Following Gonadotropin-Induced Estradiol Elevation
Time frame: Approximately 8-12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 41719160Savas B, Korucu DG, Gok G. The Effects of Supraphysiological Estrogen Levels Observed During In Vitro Fertilization Treatment on Cardiac Electrophysiology. Ann Noninvasive Electrocardiol. 2026 Mar;31(2):e70160. doi: 10.1111/anec.70160.
- Individual participant dataSharing planned: No
Related trials for In Vitro Fertilization
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilay Gök Korucu, M.D. principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization and Estradiol, run by Konya City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QTc Interval Before and After Gonadotropin-Induced Estradiol Elevation (time frame: Approximately 8-12 days from baseline to post-treatment ECG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07007416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.