Measurement of Midazolam Levels in Follicular Fluid

NCT ID: NCT03049293

Last Updated: 2021-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2019-10-01

Brief Summary

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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

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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.

Conditions

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Midazolam Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group using Propofol

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

The impact of Midazolam levels in follicular fluid.

Interventions

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Midazolam

The impact of Midazolam levels in follicular fluid.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

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Prof Dr. Human Fatemi

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Human Mo Fatemi, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Middle East Clinic

Locations

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IVI Middle East Fertilty Clinic

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/7589618

Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval.

https://www.ncbi.nlm.nih.gov/pubmed/10402383

Midazolam/ketamine sedative combination compared with fentanyl/propofol/isoflurane anaesthesia for oocyte retrieval.

Other Identifiers

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1610-ABU-074-HF

Identifier Type: -

Identifier Source: org_study_id

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