Measurement of Midazolam Levels in Follicular Fluid

Midazolam Overdose Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03049293
• Other study ID #: 1610-ABU-074-HF
• Status: Terminated
• Phase: Early Phase 1
• Start date: June 20, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: May 2021
• Source: ART Fertility Clinics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Midazolam Overdose

Intervention

Drug:
• Midazolam
The impact of Midazolam levels in follicular fluid.

Locations

Country	Name	City	State
United Arab Emirates	IVI Middle East Fertilty Clinic	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
ART Fertility Clinics LLC

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6-12 months

External Links

•   Age-specific serum anti-Müllerian hormone values for 17,120 women presenting to fertility centers within the United States
•   Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval.
•   General anesthesia versus monitored anesthesia care with remifentanil for assisted reproductive technologies: effect on pregnancy rate
•   Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice
•   Midazolam/ketamine sedative combination compared with fentanyl/propofol/isoflurane anaesthesia for oocyte retrieval.