Measurement of Midazolam Levels in Follicular Fluid

NCT03049293 | Terminated Early Phase 1

• 1 other identifier: 1610-ABU-074-HF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Midazolam Overdose

Keywords

COPD,IVF

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group using Propofol

NO INTERVENTION

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

Study group Midazolam group

EXPERIMENTAL

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

Interventions

Midazolam DRUG

The impact of Midazolam levels in follicular fluid.

Study group Midazolam group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

Location

Related Links

• 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.

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Human Mo Fatemi, MD

  IVI Middle East Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: February 10, 2017
• Study Start: June 20, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)