Midazolam OverdoseEarly Phase 1NCT03049293
Measurement of Midazolam Levels in Follicular Fluid
A Early Phase 1 study testing Midazolam in people with Midazolam Overdose, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics. The reason to measure Midazolam levels in larger size follicles in this study is to maximize the chances to get a mature oocyte and therefore develop into a potential embryo to be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Midazolam Overdose
- What is being tested?
- Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 20 Jun 2017to 1 Oct 2019
- Phase
- Early Phase 1
- 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 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertility (prim. / sec.)
- Age >18 - ≤ 38 years.
- BMI 19-30
- Stimulation in GnRH-antagonist protocol, using rFSH
- Expected normal ovarian response (6)
- At least 4 follicles with the size ≥ than 17 mm on the day of OPU
- Patients undergoing PGS
- Able to understand the aim of the study and to provide consent
Who cannot join
- History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.
- Severe male factor
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
IVI Middle East Fertilty Clinic
Abu Dhabi
About this study
Official title: Measurement of Midazolam Levels in Follicular Fluid and Correlation of Midazolam Levels in Follicular Fluid and Oocyte Quality, Fertilization Rate, Embryo Development Pattern and Euploid Status
To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.
The reason to measure Midazolam levels in larger size follicles in this study is to maximize the chances to get a mature oocyte and therefore develop into a potential embryo to be analyzed.
Read the detailed description
The correlation of Midazolam levels in follicular fluid and euploid status of the embryos is worth exploring as no data exists that suggests any influence on the quality of the embryos from using this substance for IVF since its earliest days. Measuring time lapsed from injection to first oocyte retrieval as well as time lapsed in between first and last oocyte retrieved will grand insight into the rise of levels of Midazolam inside the follicular fluid, correlated with the chromosomal status and the morphokinetic development of the euploid embryos.
- Conditions
- Midazolam Overdose
- Being tested
- Midazolam
- Keywords
- COPD,IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
The impact of Midazolam levels in follicular fluid.
| Study group | Role | What they receive |
|---|---|---|
| Control group using Propofol | No intervention | Sedation will be established by administering 100mcs of Fentanyl, and 1-1.5mg/kg of body weight of Propofol. |
| Study group Midazolam group | Experimental | Sedation will be established by administering Midazolam 1mg, 100mcs of Fentanyl, and 0.5-1mg/kg of body weight of Propofol. Further boluses of Propofol will be given according to the need of the patient and time consumed for oocyte retrieval. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .
To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start20 Jun 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: Difficulty in recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midazolam OverdoseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr. Human Fatemi, ART Fertility Clinics LLC
- Investigators
- Human Mo Fatemi, MD, Principal investigator, IVI Middle East Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049293
- Sponsor's protocol ID
- 1610-ABU-074-HF
- Status last verified
- May 2021
- First submitted
- 12 Jan 2017
- Last updated
- 6 May 2021
- 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 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Midazolam Levels in Follicular Fluid and Correlation of Midazolam Levels in Follicular Fluid and Oocyte Quality, Fertilization Rate, Embryo Development Pattern and Euploid Status
- ClinicalTrials.gov ID
- NCT03049293
- Acronym / sponsor ID
- 1610-ABU-074-HF
- Conditions
- Midazolam Overdose
- Keywords
- COPD,IVF
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting participants
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 10 Feb 2017 (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.
To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.
The reason to measure Midazolam levels in larger size follicles in this study is to maximize the chances to get a mature oocyte and therefore develop into a potential embryo to be analyzed.
Detailed description
The correlation of Midazolam levels in follicular fluid and euploid status of the embryos is worth exploring as no data exists that suggests any influence on the quality of the embryos from using this substance for IVF since its earliest days. Measuring time lapsed from injection to first oocyte retrieval as well as time lapsed in between first and last oocyte retrieved will grand insight into the rise of levels of Midazolam inside the follicular fluid, correlated with the chromosomal status and the morphokinetic development of the euploid embryos.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group using Propofol | No intervention | –Sedation will be established by administering 100mcs of Fentanyl, and 1-1.5mg/kg of body weight of Propofol. |
| Study group Midazolam group | Experimental | Drug: MidazolamSedation will be established by administering Midazolam 1mg, 100mcs of Fentanyl, and 0.5-1mg/kg of body weight of Propofol. Further boluses of Propofol will be given according to the need of the patient and time consumed for oocyte retrieval. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Infertility (prim. / sec.)
- Age >18 - ≤ 38 years.
- BMI 19-30
- Stimulation in GnRH-antagonist protocol, using rFSH
- Expected normal ovarian response (6)
Key exclusion criteria (2 listed)
- History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.
- Severe male factor
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 |
|---|---|---|
| MidazolamThe impact of Midazolam levels in follicular fluid. | Drug | Study group Midazolam group |
Primary outcome
Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .
Time frame: 6-12 months
To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.
Results and safety
The study was stopped early (reason given: Difficulty in recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval.Link provided by the sponsor.
- Midazolam/ketamine sedative combination compared with fentanyl/propofol/isoflurane anaesthesia for oocyte retrieval.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Human Mo Fatemi, MD principal investigator
IVI Middle East Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Midazolam in people with Midazolam Overdose, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 8 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 May 2021. 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 United Arab Emirates. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration . (time frame: 6-12 months). 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 6 May 2021.