Measurement of Midazolam Levels in Follicular Fluid

Early Phase 1

Terminated

• Conditions: Midazolam Overdose
• Interventions: Drug: Midazolam

• Registration Number: NCT03049293
• Lead Sponsor: ART Fertility Clinics LLC

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.

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-10
• Study Start: 2017-06-20
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-02
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group Midazolam group	Midazolam	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.

Primary Outcome Measures

Name	Time	Method
Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .	6-12 months	To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.

Trial Locations

Locations (1)

IVI Middle East Fertilty Clinic; 🇦🇪 Abu Dhabi, United Arab Emirates