NCT04160611

What Amount of Stress is Enough for a Successful Conception?

Impact of Premedication With Midazolam in Aspiration Procedures On Stress Levels During IVF Procedures

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital Sestre Milosrdnice · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine whether premedication with midazolam before oocyte aspiration in IVF procedures affects the amount of (oxidative) stress in women undergoing IVF and whether stress is also transmitted to the follicular fluid of aspirated follicles. The primary endpoint is the impact of stress during aspiration on the success of medically assisted fertilization (IVF / ICSI in the stimulated cycle).

Detailed description

The procedure of in vitro fertilisation (IVF) is used to treat the infertility problems. The procedure includes ovary aspiration, to isolate oocytes. During the aspiration the patient is sedated with short-term intravenous aesthetic. Premedication is often used in anaesthesiology, and includes drugs application 30 minutes prior to procedure to sedate and treat the anxieties of the patient. One of the most often used drugs in premedication is midazolam. As the procedure is quite stressful for the patients, our aim is to investigate the influence of midazolam premedication on the stress release during the oocyte aspiration procedure, as well as its influence on the whole IVF procedure. Therefore, patients will be divided into two groups, control and midazolam. Blood samples will be taken before and during the procedure. Stress, antioxidant parameters (with glutathione and catalase) and oxidative status will be monitored in serum and follicular fluid. The results will be correlated with subjective stress levels in the two groups in an effort to establish ties with IVF results.

Conditions

• In Vitro Fertilization
• Stress
• Midazolam Adverse Reaction
• Stress, Emotional

Interventions

Type	Name	Description
DRUG	Midazolam 7.5mg	The patient groups differ only in that respect that the intervention group will receive oral midazolam 7.5 g before oocyte aspiration.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-06-30
• Completion: 2020-10-01
• First posted: 2019-11-13
• Last updated: 2019-11-13

Locations

1 site across 1 country: Croatia