Clinical trial NCT06925633: Estrogen Levels and Postoperative Recovery in IVF Patients
Official title: The Impact of Supraphysiologic Estrogen Levels on Postoperative Recovery Quality in IVF Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: In Vitro Fertilization
Postoperative Recovery
Estrogens
Anesthesia Recovery Period
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Recovery Quality (QoR-15 Score)
timeFrame: 24 hours and 72 hours after surgery
Secondary outcomes:
measure: Postoperative Pain Intensity (NRS Score)
timeFrame: 24 and 72 hours after surgery
measure: Postoperative Nausea and Vomiting (VDS Score)
timeFrame: 24 and 72 hours after surgery
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References: