Stress ReactionNCT03248076
Effect of Fentanyl on Main Opioid Receptor (OPRM1) on Human Granulosa Cells.
An observational study of Stress Reaction and Opioid Use, run by George Papanicolaou Hospital at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction, Opioid Use
- What is being tested?
- Fentanyl Citrate
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2017to 10 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers oocyte donor
Who may be able to join
- American Physical Status I-III, BMI<30,
Who cannot join
- Heart failure
- hepatic failure, hepatitis,
- drug abuse
- receiving b blockers
- receiving b agonists (even bronchodilators)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Section of Anatomy, Aristotle University of Thessaloniki
Thessaloniki, 54124
Irene Asouhidou, MD, PhD, 2310999321, iasouh@aol.com
Evaggelos Papanikolaou, MD, PhD, +302310424294, drvagpapanikolaou@yahoo.gr
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Reaction, Opioid Use
- Being tested
- Fentanyl Citrate
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl CitrateDrug
1γ/Kg fentanyl
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fentanyl Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
fentanyl
fentanyl on blood sample and oocyte fluid
Measured: 15 minutes
Secondary outcomes (1)
cortisone
cortisone on blood sample and oocyte fluid
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start1 Apr 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion10 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Papanikolaou Evaggelos, Naidecki Robert, Pakaki Fay, Raikos Nikolaos
- Responsible party
- Principal investigator, Asouhidou Irene, George Papanicolaou Hospital
- Investigators
- Irene Asouhidou, MD, PhD, Principal investigator, Assisting Nature
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248076
- Sponsor's protocol ID
- Opioids-OPU
- Status last verified
- Dec 2017
- First submitted
- 7 Aug 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28669481Lunger 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.
PubMed 26803207Kouvaras 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.
PubMed 18706433
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fentanyl on Expression of Main Opioid Receptor (OPRM1) on Human Granulosa Cells During Ultrasound-guided Transvaginal Oocyte Retrieval.
- ClinicalTrials.gov ID
- NCT03248076
- Acronym / sponsor ID
- Opioids-OPU
- Conditions
- Stress Reaction, Opioid Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Collaborators
- Papanikolaou Evaggelos, Naidecki Robert, Pakaki Fay, Raikos Nikolaos
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 10 Oct 2018 (estimated)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl citrate | – | Drug: Fentanyl CitrateBaseline 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. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers oocyte donor
Key inclusion criteria (1 listed)
- American Physical Status I-III, BMI<30,
Key exclusion criteria (5 listed)
- Heart failure
- hepatic failure, hepatitis,
- drug abuse
- receiving b blockers
- receiving b agonists (even bronchodilators)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl Citrate1γ/Kg fentanyl | Drug | Fentanyl citrate |
Primary outcome
fentanyl
Time frame: 15 minutes
fentanyl on blood sample and oocyte fluid
1 secondary outcome
cortisone
Time frame: 15 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Background: PubMed 28669481Bottcher 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.
- Background: PubMed 26803207Lunger 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.
- Background: PubMed 18706433Kouvaras 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Asouhidou, MD, PhD principal investigator
Assisting Nature
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Reaction and Opioid Use, run by George Papanicolaou Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Asouhidou, MD, PhD (00302310999321, iasouh@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fentanyl (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248076, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.