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Measurement of Midazolam Levels in Follicular Fluid

Primary Purpose

Midazolam Overdose

Status
Terminated
Phase
Early Phase 1
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Midazolam
Sponsored by
ART Fertility Clinics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Midazolam Overdose focused on measuring COPD,IVF

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts 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

Sites / Locations

  • IVI Middle East Fertilty Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group using Propofol

Study group Midazolam group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2017
Last Updated
May 2, 2021
Sponsor
ART Fertility Clinics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03049293
Brief Title
Measurement of Midazolam Levels in Follicular Fluid
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting participants
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ART Fertility Clinics LLC

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Midazolam Overdose
Keywords
COPD,IVF

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group using Propofol
Arm Type
No Intervention
Arm Description
Sedation will be established by administering 100mcs of Fentanyl, and 1-1.5mg/kg of body weight of Propofol.
Arm Title
Study group Midazolam group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
The impact of Midazolam levels in follicular fluid.
Primary Outcome Measure Information:
Title
Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .
Description
To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.
Time Frame
6-12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Human Mo Fatemi, MD
Organizational Affiliation
IVI Middle East Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVI Middle East Fertilty Clinic
City
Abu Dhabi
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/7589618
Description
Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval.
URL
https://www.ncbi.nlm.nih.gov/pubmed/10402383
Description
Midazolam/ketamine sedative combination compared with fentanyl/propofol/isoflurane anaesthesia for oocyte retrieval.
URL
http://humupd.oxfordjournals.org/content/20/1/124.long
Description
Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice

Learn more about this trial

Measurement of Midazolam Levels in Follicular Fluid

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