- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06925633
Estrogen Levels and Postoperative Recovery in IVF Patients
The Impact of Supraphysiologic Estrogen Levels on Postoperative Recovery Quality in IVF Patients: A Prospective Observational Study
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey (Türkiye), 42090
- Konya City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours and 72 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity (NRS Score)
Time Frame: 24 and 72 hours after surgery
|
Assessed using the Numerical Rating Scale (NRS) where 0 indicates no pain and 10 indicates worst imaginable pain.
|
24 and 72 hours after surgery
|
|
Postoperative Nausea and Vomiting (VDS Score)
Time Frame: 24 and 72 hours after surgery
|
Evaluated using the Verbal Descriptive Scale (VDS); scale ranges from 0 (none) to 4 (severe nausea and vomiting).
|
24 and 72 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2.11.2024-33440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on In Vitro Fertilization
-
Centrum Clinic IVF CenterRecruitingFertilization | Fertilization in VitroTurkey (Türkiye)
-
University of Central FloridaThe IVF Center at Winter ParkRecruitingInVitro Fertilization | In Vitro Fertilisation (IVF) Treatment | Ovarian Aging | In Vitro Fertilization OutcomeUnited States
-
The First Hospital of Jilin UniversityRecruitingFertilization in VitroChina
-
Heilongjiang University of Chinese MedicineNot yet recruitingIn Vitro FertilizationChina
-
Mỹ Đức HospitalVrije Universiteit BrusselCompleted
-
Organon and CoCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompleted
-
Rambam Health Care CampusUnknownFertilization in Vitro