In Vitro FertilizationNCT06925633
Estrogen Levels and Postoperative Recovery in IVF Patients
An observational study of In Vitro Fertilization and Postoperative Recovery, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the relationship between supraphysiologic serum estrogen levels and postoperative recovery quality in patients undergoing IVF procedures under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- In Vitro Fertilization, Postoperative Recovery, Estrogens
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 31 Dec 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 45 years
- Women only
- Adult
Study population: The study population consists of adult female patients aged 18 to 45 years undergoing transvaginal oocyte retrieval under general anesthesia as part of an IVF procedure. All participants will have ASA physical status I or II and be able to provide informed consent.
Who may be able to join
- Female patients aged between 18 and 45 years
- ASA physical status I or II
- Scheduled for transvaginal oocyte retrieval under general anesthesia as part of an IVF procedure
- Willing and able to provide written informed consent
- Able to understand and complete study questionnaires (QoR-15, HADS)
Who cannot join
- ASA physical status III or IV
- History of severe renal, hepatic, respiratory, or cardiovascular disease
- Current or chronic use of psychotropic medications
- Chronic use of opioids or benzodiazepines
- Known psychiatric or neurological disorders that may interfere with study participation
- Inability to provide informed consent or complete study questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Supraphysiologic Estrogen Levels on Postoperative Recovery Quality in IVF Patients: A Prospective Observational Study
This prospective observational study aims to evaluate the relationship between supraphysiologic serum estrogen levels and postoperative recovery quality in patients undergoing IVF procedures under general anesthesia. Estrogen is known to play a role in pain modulation and emotional responses, both of which influence postoperative recovery. The primary outcome is the quality of recovery score (QoR-15), and secondary outcomes include postoperative pain, nausea and vomiting, and discharge time. A total of 100 adult female patients will be included. The study seeks to provide better insight into how elevated estrogen levels may impact patient outcomes after anesthesia.
Read the detailed description
Postoperative recovery is a multidimensional and complex process influenced by pain, nausea and vomiting, emotional and functional factors. IVF (In Vitro Fertilization) treatments involve controlled ovarian hyperstimulation, which causes supraphysiologic increases in serum estrogen levels. Elevated estrogen is thought to affect pain modulation and inflammatory pathways and has been associated with increased symptoms such as nausea and mood fluctuations.
This prospective observational study aims to investigate the relationship between serum estrogen concentration and the quality of recovery in patients undergoing IVF-related transvaginal oocyte retrieval under general anesthesia. A total of 100 ASA I-II adult female patients between the ages of 18 and 45 will be enrolled.
Patients will be grouped based on their estradiol (E2) levels measured as part of the routine IVF procedure. E2 levels above 350 pg/ml will be defined as supraphysiologic. The primary outcome is the postoperative recovery quality assessed using the QoR-15 questionnaire at 24 and 72 hours postoperatively. Secondary outcomes include postoperative pain intensity (measured by the Numerical Rating Scale), nausea and vomiting (assessed by Verbal Descriptive Scale), and time to discharge (evaluated using the Modified Aldrete Score). Preoperative anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).
This study aims to contribute to improved anesthetic and perioperative management of IVF patients with elevated estrogen levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Recovery Quality (QoR-15 Score)
Assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 and 72 hours postoperatively. The score ranges from 0 to 150, with higher scores indicating better recovery.
Measured: 24 hours and 72 hours after surgery
Secondary outcomes (2)
Postoperative Pain Intensity (NRS Score)
Assessed using the Numerical Rating Scale (NRS) where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: 24 and 72 hours after surgery
Postoperative Nausea and Vomiting (VDS Score)
Evaluated using the Verbal Descriptive Scale (VDS); scale ranges from 0 (none) to 4 (severe nausea and vomiting).
Measured: 24 and 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start20 Apr 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925633
- Sponsor's protocol ID
- 2.11.2024-33440
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Supraphysiologic Estrogen Levels on Postoperative Recovery Quality in IVF Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06925633
- Acronym / sponsor ID
- 2.11.2024-33440
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Apr 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 aims to evaluate the relationship between supraphysiologic serum estrogen levels and postoperative recovery quality in patients undergoing IVF procedures under general anesthesia. Estrogen is known to play a role in pain modulation and emotional responses, both of which influence postoperative recovery. The primary outcome is the quality of recovery score (QoR-15), and secondary outcomes include postoperative pain, nausea and vomiting, and discharge time. A total of 100 adult female patients will be included. The study seeks to provide better insight into how elevated estrogen levels may impact patient outcomes after anesthesia.
Detailed description
Postoperative recovery is a multidimensional and complex process influenced by pain, nausea and vomiting, emotional and functional factors. IVF (In Vitro Fertilization) treatments involve controlled ovarian hyperstimulation, which causes supraphysiologic increases in serum estrogen levels. Elevated estrogen is thought to affect pain modulation and inflammatory pathways and has been associated with increased symptoms such as nausea and mood fluctuations.
This prospective observational study aims to investigate the relationship between serum estrogen concentration and the quality of recovery in patients undergoing IVF-related transvaginal oocyte retrieval under general anesthesia. A total of 100 ASA I-II adult female patients between the ages of 18 and 45 will be enrolled.
Patients will be grouped based on their estradiol (E2) levels measured as part of the routine IVF procedure. E2 levels above 350 pg/ml will be defined as supraphysiologic. The primary outcome is the postoperative recovery quality assessed using the QoR-15 questionnaire at 24 and 72 hours postoperatively. Secondary outcomes include postoperative pain intensity (measured by the Numerical Rating Scale), nausea and vomiting (assessed by Verbal Descriptive Scale), and time to discharge (evaluated using the Modified Aldrete Score). Preoperative anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS).
This study aims to contribute to improved anesthetic and perioperative management of IVF patients with elevated estrogen levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study population consists of adult female patients aged 18 to 45 years undergoing transvaginal oocyte retrieval under general anesthesia as part of an IVF procedure. All participants will have ASA physical status I or II and be able to provide informed consent.
Key inclusion criteria (5 listed)
- Female patients aged between 18 and 45 years
- ASA physical status I or II
- Scheduled for transvaginal oocyte retrieval under general anesthesia as part of an IVF procedure
- Willing and able to provide written informed consent
- Able to understand and complete study questionnaires (QoR-15, HADS)
Key exclusion criteria (6 listed)
- ASA physical status III or IV
- History of severe renal, hepatic, respiratory, or cardiovascular disease
- Current or chronic use of psychotropic medications
- Chronic use of opioids or benzodiazepines
- Known psychiatric or neurological disorders that may interfere with study participation
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
Postoperative Recovery Quality (QoR-15 Score)
Time frame: 24 hours and 72 hours after surgery
Assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 and 72 hours postoperatively. The score ranges from 0 to 150, with higher scores indicating better recovery.
2 secondary outcomes
Postoperative Pain Intensity (NRS Score)
Time frame: 24 and 72 hours after surgery
Postoperative Nausea and Vomiting (VDS Score)
Time frame: 24 and 72 hours after surgery
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 6 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
Related trials for In Vitro Fertilization
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Recovery, 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 6 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 6 Jan 2026. 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?
Postoperative Recovery Quality (QoR-15 Score) (time frame: 24 hours and 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.