Measurement of Midazolam Levels in Follicular Fluid

ART Fertility Clinics LLC

Status and phase: Terminated; Early Phase 1

Conditions: Midazolam Overdose

Treatments: Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03049293

1610-ABU-074-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control group using Propofol

No Intervention group

Description:

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

Study group Midazolam group

Experimental group

Description:

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.

Treatment:

Drug: Midazolam