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TerminatedNCT03049293Updated May 6, 2021

Measurement of Midazolam Levels in Follicular Fluid

An Early Phase 1 interventional study of Midazolam in Midazolam Overdose, sponsored by ART Fertility Clinics LLC. Terminated at 1 site in United Arab Emirates. Open to female participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-06.

Sponsored by ART Fertility Clinics LLC · Early Phase 1, Interventional, and Treatment

Why this study was terminated
Difficulty in recruiting participants
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
Female
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Study 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 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.

02

Conditions studied

  • Midazolam Overdose

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Keywords

  • COPD,IVF
03

In context

Drug Overdose

139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 98 interventional studies indexed under Drug Overdose.

Browse Drug Overdose studies →

Lead sponsor

ART Fertility Clinics LLC is the lead sponsor of 51 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.
  • Severe male factor
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    Control group using Propofol

    Sedation will be established by administering 100mcs of Fentanyl, and 1-1.5mg/kg of body weight of Propofol.

  • Experimental
    Study group Midazolam group

    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.

    Drug: Midazolam

Interventions

  • DrugMidazolam

    The impact of Midazolam levels in follicular fluid.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-12 months

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Study locations

1 site
  • IVI Middle East Fertilty Clinic
    Abu Dhabi, United Arab Emirates
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03049293
Lead sponsor
ART Fertility Clinics LLC
Responsible party
Prof Dr. Human Fatemi (Medical Director, ART Fertility Clinics LLC) — Principal investigator
First posted
Feb 10, 2017
Start date
Jun 20, 2017
Primary completion
Oct 1, 2019
Completion
Oct 1, 2019
Last update
May 6, 2021

Study contacts

Human Mo Fatemi, MD
principal investigator · IVI Middle East Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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