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Measurement of Midazolam Levels in Follicular Fluid

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

Status
Terminated
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03049293
Enrollment
30
Registered
2017-02-10
Start date
2017-06-20
Completion date
2019-10-01
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Midazolam Overdose

Keywords

COPD,IVF

Brief 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.

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.

Interventions

DRUGMidazolam

The impact of Midazolam levels in follicular fluid.

Sponsors

ART Fertility Clinics LLC
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .6-12 monthsTo determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026