Effect of Fentanyl on Main Opioid Receptor (OPRM1) on Human Granulosa Cells.

Effect of Fentanyl on Expression of Main Opioid Receptor (OPRM1) on Human Granulosa Cells During Ultrasound-guided Transvaginal Oocyte Retrieval.

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.

Study Overview

• Status: Unknown
• Conditions: Opioid Use; Stress Reaction
• Intervention / Treatment: Drug: Fentanyl Citrate

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Greece
  • Thessaloníki, Greece, 54124
    • Recruiting
    • Section of Anatomy, Aristotle University of Thessaloniki
    • Contact: Irene Asouhidou, MD, PhD; Phone Number: 2310999321; Email: iasouh@aol.com
    • Contact: Evaggelos Papanikolaou, MD, PhD; Phone Number: +302310424294; Email: drvagpapanikolaou@yahoo.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 32 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers oocyte donor

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fentanyl citrate; Baseline blood sample and oocyte fluid will be collected under propofol anesthesia. Fifteen minutes after administration of 1γ/kgfentanyl, it will be collected again blood sample and oocyte fluid. Cortisone and fentanyl level will be measured in all samples.	Drug: Fentanyl Citrate; 1γ/Kg fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fentanyl	fentanyl on blood sample and oocyte fluid	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cortisone	cortisone on blood sample and oocyte fluid	15 min

Collaborators and Investigators

• Sponsor: George Papanicolaou Hospital
• Collaborators: Papanikolaou Evaggelos; Naidecki Robert; Pakaki Fay; Raikos Nikolaos
• Investigators: Principal Investigator: Irene Asouhidou, MD, PhD, Assisting Nature

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): October 10, 2018

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: Opioids-OPU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No