NCT06925633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

April 7, 2025

Last Update Submit

December 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours and 72 hours after surgery

Secondary Outcomes (2)

  • Postoperative Pain Intensity (NRS Score)

    24 and 72 hours after surgery

  • Postoperative Nausea and Vomiting (VDS Score)

    24 and 72 hours after surgery

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, 42090, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Anesthesiology and Reanimation

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 13, 2025

Study Start

April 20, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared.

Locations