Measurement of Midazolam Levels in Follicular Fluid

• Sponsor: ART Fertility Clinics LLC (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03049293
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.4
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Midazolam Overdose	Drug: Midazolam	Early Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 20, 2017
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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; The impact of Midazolam levels in follicular fluid.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• Sexes Eligible for Study: 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:

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

• Severe male factor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IVI Middle East Fertilty Clinic	Abu Dhabi		United Arab Emirates

Sponsors and Collaborators

• ART Fertility Clinics LLC

Investigators

• Principal Investigator: Human Mo Fatemi, MD, IVI Middle East Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval.
• Midazolam/ketamine sedative combination compared with fentanyl/propofol/isoflurane anaesthesia for 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
• Age-specific serum anti-Müllerian hormone values for 17,120 women presenting to fertility centers within the United States

Publications

None provided.

• Responsible Party: Prof Dr. Human Fatemi, Medical Director, ART Fertility Clinics LLC
• ClinicalTrials.gov Identifier: NCT03049293
• Other Study ID Numbers: 1610-ABU-074-HF
• First Posted: Feb 10, 2017
• Last Update Posted: May 6, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Prof Dr. Human Fatemi, Medical Director, ART Fertility Clinics LLC: COPD,IVF
• Additional relevant MeSH terms: Drug Overdose; Midazolam

Study Results

No Results Posted as of May 6, 2021