Stress Clinical Trial
Official title:
Impact of Premedication With Midazolam in Aspiration Procedures On Stress Levels During IVF Procedures
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).
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Center Sestre milosrdnice | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University Hospital "Sestre Milosrdnice" |
Croatia,
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 |
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