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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03248076
• Other study ID #: Opioids-OPU
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2017
• Last updated: December 13, 2017
• Start date: April 1, 2017
• Est. completion date: October 10, 2018

Study information

• Verified date: December 2017
• Source: George Papanicolaou Hospital
• Contact: Irene Asouhidou, MD, PhD
• Phone: 00302310999321
• Email: iasouh[@]aol.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 10, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 32 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Stress
• Opioid Use
• Stress Reaction

Intervention

Drug:
• Fentanyl Citrate
1?/Kg fentanyl

Locations

Country	Name	City	State
Greece	Section of Anatomy, Aristotle University of Thessaloniki	Thessaloníki

Sponsors (5)

Lead Sponsor	Collaborator
George Papanicolaou Hospital	Naidecki Robert, Pakaki Fay, Papanikolaou Evaggelos, Raikos Nikolaos

Country where clinical trial is conducted

Greece, 

References & Publications (3)

Böttcher 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. Review. — View 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. — View Citation

Lunger F, Vehmas AP, Fürnrohr 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fentanyl	fentanyl on blood sample and oocyte fluid	15 minutes
Secondary	cortisone	cortisone on blood sample and oocyte fluid	15 min