What Amount of Stress is Enough for a Successful Conception?
NCT ID: NCT04160611
Last Updated: 2019-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2019-09-01
2020-10-01
Brief Summary
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Detailed Description
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The results will be correlated with subjective stress levels in the two groups in an effort to establish ties with IVF results.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No Premedication with Midazolam
Women in the control group will undergo aspiration under the control of transvaginal ultrasound of one or more mature follicles (TUGOR - transvaginal ultrasound guided oocyte retrieval) under short term general anesthesia.
No interventions assigned to this group
Premedication with Midazolam
Patients will be randomly divided into two groups, control and midazolam. The midazolam group will receive midazolam premedication in such a way that 7.5mg midazolam will be taken orally 30 minutes before the aspiration procedure. Because midazolam causes sedation, the woman will be monitored by midazolam after medical premedication to avoid possible complications and will not be allowed to get out of bed on her own for 30 minutes. After 30 min, all women, both test and control group, will begin aspiration under the control of transvaginal ultrasound of one or more mature follicles (TUGOR - transvaginal ultrasound guided oocyte retrieval) under short term general anesthesia.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Hospital Sestre Milosrdnice
OTHER
Responsible Party
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Andro Košec, MD, PhD
Consultant Otorhinolaryngologist and Head and Neck Surgeon
Principal Investigators
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Vesna Košec, MD, PhD
Role: STUDY_CHAIR
Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia
Locations
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University Hospital Center Sestre milosrdnice
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EP-9157/18-14
Identifier Type: -
Identifier Source: org_study_id
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