Impact of Midazolam Premedication in Reducing Stress During Oocyte Aspiration: A Prospective Interventional Randomized Parallel Single-center Pilot Study

Phase 4

• Conditions: N97; F43; Female infertility; Reaction to severe stress, and adjustment disorders

• Registration Number: DRKS00021657
• Lead Sponsor: Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre milosrdnice, Zagreb, Croatia School of Medicine, University of Zagreb, Šalata 3, 10000 Zagreb, Croatia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-05-03
• Study Start: 2020-05-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

The study includes healthy women over 18 years of age that are planned for oocyte aspiration as part of an IVF procedure.

Exclusion Criteria

Incomplete follow-up and failure to obtain informed consent.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures will be levels of stress markers in the serum and follicular fluid prior to midazolam administration, immediately prior to oocyte aspiration and 2 hours after aspiration.

Secondary Outcome Measures

Name	Time	Method
As a secondary outcome, the number of successful pregnancies will be recorded during post-procedural follow up, defined as beta HCG values increase and ultrasound confirmation of pregnancy 8 weeks after the procedure.