Measurement of Midazolam Levels in Follicular Fluid

Study Overview
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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.

Official Title
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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

Conditions
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Midazolam Overdose

Intervention / Treatment
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* Drug: Midazolam


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group using Propofol<br>Sedation will be established by administering 100mcs of Fentanyl, and 1-1.5mg/kg of body weight of Propofol. | |
| Experimental: Study group Midazolam group<br>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<br>* The impact of Midazolam levels in follicular fluid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD,IVF