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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00021657
Enrollment
60
Registered
2020-05-05
Start date
2018-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N97 F43

Interventions

Group 1: A total of 60 patients will be randomized into two treatment groups: the group receiving midazolam premedication, and the control group that does not. Standard treatment (golden standard) is

Sponsors

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
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Incomplete follow-up and failure to obtain informed consent.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Croatia

Contacts

Public ContactAndro Košec

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

andro.kosec@yahoo.com+385989817156

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026