What Amount of Stress is Enough for a Successful Conception?

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04160611
• Other study ID #: EP-9157/18-14
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2019
• Source: University Hospital "Sestre Milosrdnice"
• Contact: Andro Košec, MD, PhD
• Phone: +385989817156
• Email: andro.kosec[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent, healthy women undergoing IVF procedures for the first time

Exclusion Criteria:

• Refusal to enroll, chronic endocrine and psychiatric illnesses that might affect baseline stress levels

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Croatia	University Hospital Center Sestre milosrdnice	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital "Sestre Milosrdnice"

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress Levels in Premedicated Women	All patients in the midazolam group will be sampled with 5 ml venepuncture prior to midazolam administration, just before the procedure, 2 hours after the procedure. A follicular fluid sample will be taken at the procedure. Samples will be stored in the freezer at -80°C. The total antioxidant capacity (TAC) and total oxidation capacity (TOC) of commercially available kits will be determined from plasma and follicular fluid. Whole blood will determine total glutathione and catalase activity. In addition to the total oxidation capacity, the amount of HNE-protein conjugates will be determined from the follicular fluid as an indicator of lipid peroxidation, and the Patients will be monitored after the aspiration procedure, and the success of the procedure of medically assisted fertilization, ie number of pregnancies, in the test and control group will be monitored.	3 hours post-surgery