In Vitro FertilizationPhase 3NCT04160611
What Amount of Stress is Enough for a Successful Conception?
A Phase 3 study testing Midazolam 7.5mg in people with In Vitro Fertilization and Stress, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- In Vitro Fertilization, Stress, Midazolam Adverse Reaction
- What is being tested?
- Midazolam 7.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2019to 1 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent, healthy women undergoing IVF procedures for the first time
Who cannot join
- Refusal to enroll, chronic endocrine and psychiatric illnesses that might affect baseline stress levels
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Center Sestre milosrdnice
Zagreb, 10000
Andro Košec, MD, PhD, +385989817156, andro.kosec@yahoo.com
Maja Pešić, MD, +38513787237, majapesic1980@gmail.com
About this study
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).
Read the 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.
- Being tested
- Midazolam 7.5mg
- Keywords
- IVF, stress, midazolam, premedication
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam 7.5mgDrug
The patient groups differ only in that respect that the intervention group will receive oral midazolam 7.5 g before oocyte aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Premedication with Midazolam | Experimental | 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. Receives: Drug: Midazolam 7.5mg |
| No Premedication with Midazolam | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 -80⁰C. 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.
Measured: 3 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Sep 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two randomized groups receiving midazolam/not receiving midazolam premedication before oocyte aspiration procedures as part of IVF procedures
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andro Košec, MD, PhD, University Hospital
- Investigators
- Vesna Košec, MD, PhD, Study chair, Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160611
- Sponsor's protocol ID
- EP-9157/18-14
- Status last verified
- Nov 2019
- First submitted
- 9 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Premedication With Midazolam in Aspiration Procedures On Stress Levels During IVF Procedures
- ClinicalTrials.gov ID
- NCT04160611
- Acronym / sponsor ID
- EP-9157/18-14
- Keywords
- IVF, stress, midazolam, premedication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two randomized groups receiving midazolam/not receiving midazolam premedication before oocyte aspiration procedures as part of IVF procedures
| Arm | Type | Receives |
|---|---|---|
| Premedication with Midazolam | Experimental | Drug: Midazolam 7.5mgPatients 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. |
| No Premedication with Midazolam | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Informed consent, healthy women undergoing IVF procedures for the first time
Key exclusion criteria (1 listed)
- Refusal to enroll, chronic endocrine and psychiatric illnesses that might affect baseline stress levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam 7.5mgThe patient groups differ only in that respect that the intervention group will receive oral midazolam 7.5 g before oocyte aspiration. | Drug | Premedication with Midazolam |
Primary outcome
Stress Levels in Premedicated Women
Time frame: 3 hours post-surgery
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 -80⁰C. 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for In Vitro Fertilization
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vesna Košec, MD, PhD study chair
Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midazolam 7.5mg in people with In Vitro Fertilization and Stress, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andro Košec, MD, PhD (+385989817156, andro.kosec@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Levels in Premedicated Women (time frame: 3 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.