Trial | NCT03049293  Report issue

Title

Measurement of Midazolam Levels in Follicular Fluid
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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    midazolam ...

  • Study Participants

    30
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.
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 Started
Jun 20
2017
Primary Completion
Oct 01
2019
Study Completion
Oct 01
2019
Last Update
May 06
2021

Drug Midazolam

The impact of Midazolam levels in follicular fluid.

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.

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
No Results Posted