Clinical trial NCT03248076: Effect of Fentanyl on Main Opioid Receptor (OPRM1) on Human Granulosa Cells.
Official title: Effect of Fentanyl on Expression of Main Opioid Receptor (OPRM1) on Human Granulosa Cells During Ultrasound-guided Transvaginal Oocyte Retrieval.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Reaction
Opioid Use
Lead sponsor: George Papanicolaou Hospital
Sponsor class: OTHER
Collaborators: name: Papanikolaou Evaggelos
name: Naidecki Robert
name: Pakaki Fay
name: Raikos Nikolaos
First posted: 2017-08-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers oocyte donor

Brief summary: Opioids is known that produce not only analgesia but also hyperalgesia through activation of central glutaminergic system-GABA. At the same time, recently it was found that the main opioid receptor (OPRM1) is present on human granulosa cells and exogenous opiates and their antagonists can influence granulosa cell vascular endothelial growth factor (VEGF) production via OPRM1, causing ovarian hyperstimulation syndrome.

This study aims to investigate if a single exposure to opioids is enough to produce activation of stress mechanism during oocyte retrieval.

Detailed description: The main opioid receptor (OPRM1) is present on human granulosa cells and exogenous opiates and their antagonists can influence granulosa cell vascular endothelial growth factor (VEGF) production via OPRM1, causing ovarian hyperstimulation syndrome.

This study aims to investigate if a single exposure to opioids is enough to produce activation of stress mechanism during ultrasound-guided oocyte retrieval. It will be measured the level of cortisone before and 15min after iv administration of fentanyl on blood and on oocyte fluid.

Eligibility criteria: Inclusion Criteria:

* American Physical Status I-III, BMI\<30,

Exclusion Criteria:

* Heart failure
* hepatic failure, hepatitis,
* drug abuse
* receiving b blockers
* receiving b agonists (even bronchodilators)

Primary outcomes:
measure: fentanyl
timeFrame: 15 minutes
Secondary outcomes:
measure: cortisone
timeFrame: 15 min
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Section of Anatomy, Aristotle University of Thessaloniki
Study officials:
affiliation: Assisting Nature
name: Irene Asouhidou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bottcher B, Seeber B, Leyendecker G, Wildt L. Impact of the opioid system on the reproductive axis. Fertil Steril. 2017 Aug;108(2):207-213. doi: 10.1016/j.fertnstert.2017.06.009. Epub 2017 Jun 29.
citation: Lunger F, Vehmas AP, Furnrohr BG, Sopper S, Wildt L, Seeber B. Opiate receptor blockade on human granulosa cells inhibits VEGF release. Reprod Biomed Online. 2016 Mar;32(3):316-22. doi: 10.1016/j.rbmo.2015.12.006. Epub 2016 Jan 6.
citation: Kouvaras E, Asprodini EK, Asouchidou I, Vasilaki A, Kilindris T, Michaloudis D, Koukoutianou I, Papatheodoropoulos C, Kostopoulos G. Fentanyl treatment reduces GABAergic inhibition in the CA1 area of the hippocampus 24 h after acute exposure to the drug. Neuropharmacology. 2008 Dec;55(7):1172-82. doi: 10.1016/j.neuropharm.2008.07.025. Epub 2008 Jul 26.