Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05958914
Status:
RECRUITING
Last Update Posted:
2023-07-25
First Post:
2023-06-12
Brief Title:
Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS
Sponsor:
University Of Perugia
Organization:
University Of Perugia
Study Overview
Official Title:
Evaluation of Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCO-NP
Brief Summary:
The goal of this clinical trial is to characterize PCOS in terms of neuropeptide expression and to make the comparison between women with and without PCOS by going to analyze venous blood samples taken during the three phases of the ovarian cycle and follicular fluid taken during the ovulatory phase as part of the oocyte pick-up Specifically the expression of neuropeptides such as CGRP SP VIP and enkephalins in the three phases of the ovarian cycle follicular phase ovulatory phase and luteal phase will be evluated in three groups of women afferent to the medically assisted reproduction centre In particular Group 1 control will include women with regular ovarian cycle Group 2 will include non-PCOS women undergoing ovarian stimulation and ICSI treatment finally Group 3 will include women with PCOS undergoing ovarian stimulation and ICSI treatment
The main questions it aims to answer are
Is there a fluctuation in blood neuropeptides concentrations of women with normal ovarian cycles during the three phases of the ovarian cycle
Do PCOS women has altered levels of blood and follicolar fluid concentration of neuropepides with respect to non-PCOS individuals
Is blood and follicolar fluid concentration of neuropeptide modulated by protocols of ovarian stimulation
Participants of Group 1 will follow the ovarian monitoring protocol during which blood samples will be taken at the three phases of the ovarian cycle
Participants of Group 2 and 3 will undergo ovarian stimulation and ICSI treatment followed by blood and follicular fluid sampling at the specified cycle phases
Researchers will compare the control Group 1 with Group 2 and 3 to see if there is a significative difference in the concentration of blood neuropeptides between the three groups at the same phase of the ovarian cycle
Moreover they will evaluate if there is there significant different concentration of neuropeptides in follicolar fluid between group 2 and 3 during the ovulatory phase
The main questions it aims to answer are
Is there a fluctuation in blood neuropeptides concentrations of women with normal ovarian cycles during the three phases of the ovarian cycle
Do PCOS women has altered levels of blood and follicolar fluid concentration of neuropepides with respect to non-PCOS individuals
Is blood and follicolar fluid concentration of neuropeptide modulated by protocols of ovarian stimulation
Participants of Group 1 will follow the ovarian monitoring protocol during which blood samples will be taken at the three phases of the ovarian cycle
Participants of Group 2 and 3 will undergo ovarian stimulation and ICSI treatment followed by blood and follicular fluid sampling at the specified cycle phases
Researchers will compare the control Group 1 with Group 2 and 3 to see if there is a significative difference in the concentration of blood neuropeptides between the three groups at the same phase of the ovarian cycle
Moreover they will evaluate if there is there significant different concentration of neuropeptides in follicolar fluid between group 2 and 3 during the ovulatory phase
Detailed Description:
This project aims to investigate the neurosensory mechanisms underlying one of the most common disorders related to folliculogenesis such as PCOS The study aims to characterize PCOS in terms of neuropeptide expression and to make the comparison between women with and without PCOS by going to analyze venous blood samples taken during the three phases of the ovarian cycle and follicular fluid taken during the ovulatory phase as part of the oocyte pick-up Specifically the expression of neuropeptides such as CGRP SP VIP and enkephalins in the three phases of the ovarian cycle follicular phase ovulatory phase and luteal phase in the three groups of women considered will be evaluated
Study design
The study will enroll 45 total patients referred to the PMA Center divided into 3 groups of 15 patients each Group 1 control women with regular ovarian cycle Group 2- non-PCOS women undergoing ovarian stimulation and ICSI treatment Group 3- women with PCOS undergoing ovarian stimulation and ICSI treatment
The study will have a total duration of 24 months divided as follows
Pre-phase monitoring and enrollment of subjects 20 months
Group 1 will follow the ovarian monitoring protocol during which blood samples will be taken at the three stages of the ovarian cycle
Group 2 and 3 will undergo ovarian stimulation and ICSI treatment taken with blood and follicular fluid samples at the specified cycle phases
Performance of chemicalbiochemical analysis performed at the electrophysiological laboratory of the University of Perugia 2 months
Performance of statistical tests and processing of the data obtained 2 months
Subjects will be given a 4 mL venous blood draw as per regular clinical practice to perform hormone dosing during ovarian cycle monitoring
No diagnostic tests outside of routine clinical practice are planned and patients will not be required to travel to the PMA Center for additional visits beyond those required by regular clinical practice
Subjects and Recruitment Location 45 patients will be recruited 15 women with a diagnosis of PCOS and 30 non-PCOS women at the medically assisted reproduction Center of the Perugia Hospital Head Prof S Gerli
MATERIALS AND METHODS
GROUP 1 Patients as per normal clinical practice will undergo three blood draws in the follicular ovulatory and luteal phases
GROUP 2 and 3 Patients will undergo ovarian stimulation treatment with gonadotropins and egg retrieval As part of this process as per clinical practice blood and follicular fluid sampling will be performed
Methods Biological Material Collection During ovarian cycle monitoring a venous blood sampling will be performed in the morning after at least 10 hours of fasting in patients during the phases described in Table 1 A follicular fluid sample will also be taken during oocyte pick-up group 2 and 3 Specifically an aliquot of blood sample which follicular fluid will be evaluated to assay the level of neuropeptides CGRP SP VIP and enkephalins The level of CGRP will be measured using an extraction-free enzyme immunoassay kit Peninsula laboratories LLC CA USA following the manufacturers protocol For the quantitative measurement of human substance P the Human Substance P Enzyme ELISA Assay Kit ELK1453-96T - Twin Elix srl will be used For VIP the ELISA Kit for Human VIP ELK1453-96T - Twin Elix srl will be used and for the enkephalins assay the ELISA Kit for Human Enkephalins ELK5246-96T - Twin Elix srl will be used Neuropeptide assays will be conducted at the Physiology Laboratory of the Department of Chemistry Biology and Biotechnology University of Perugia in collaboration with Prof Fioretti
Sera will also be analyzed for fasting glucose triglycerides TG total cholesterol TC high-density lipoprotein cholesterol HDL insulin dehydroepiandrosterone sulfate DHEAS sex hormone-binding globulin SHBG progesterone estradiol follicle-stimulating hormone FSH LH and total testosterone Serum concentrations of glucose hexokinase total cholesterol CHOD-PAP and triglycerides GPO-PAP will also be measured using standard enzymatic methods Roche Diagnostics IN USA with a fully automated analyzer Roche Modular PE Roche Diagnostics IN USA
Study design
The study will enroll 45 total patients referred to the PMA Center divided into 3 groups of 15 patients each Group 1 control women with regular ovarian cycle Group 2- non-PCOS women undergoing ovarian stimulation and ICSI treatment Group 3- women with PCOS undergoing ovarian stimulation and ICSI treatment
The study will have a total duration of 24 months divided as follows
Pre-phase monitoring and enrollment of subjects 20 months
Group 1 will follow the ovarian monitoring protocol during which blood samples will be taken at the three stages of the ovarian cycle
Group 2 and 3 will undergo ovarian stimulation and ICSI treatment taken with blood and follicular fluid samples at the specified cycle phases
Performance of chemicalbiochemical analysis performed at the electrophysiological laboratory of the University of Perugia 2 months
Performance of statistical tests and processing of the data obtained 2 months
Subjects will be given a 4 mL venous blood draw as per regular clinical practice to perform hormone dosing during ovarian cycle monitoring
No diagnostic tests outside of routine clinical practice are planned and patients will not be required to travel to the PMA Center for additional visits beyond those required by regular clinical practice
Subjects and Recruitment Location 45 patients will be recruited 15 women with a diagnosis of PCOS and 30 non-PCOS women at the medically assisted reproduction Center of the Perugia Hospital Head Prof S Gerli
MATERIALS AND METHODS
GROUP 1 Patients as per normal clinical practice will undergo three blood draws in the follicular ovulatory and luteal phases
GROUP 2 and 3 Patients will undergo ovarian stimulation treatment with gonadotropins and egg retrieval As part of this process as per clinical practice blood and follicular fluid sampling will be performed
Methods Biological Material Collection During ovarian cycle monitoring a venous blood sampling will be performed in the morning after at least 10 hours of fasting in patients during the phases described in Table 1 A follicular fluid sample will also be taken during oocyte pick-up group 2 and 3 Specifically an aliquot of blood sample which follicular fluid will be evaluated to assay the level of neuropeptides CGRP SP VIP and enkephalins The level of CGRP will be measured using an extraction-free enzyme immunoassay kit Peninsula laboratories LLC CA USA following the manufacturers protocol For the quantitative measurement of human substance P the Human Substance P Enzyme ELISA Assay Kit ELK1453-96T - Twin Elix srl will be used For VIP the ELISA Kit for Human VIP ELK1453-96T - Twin Elix srl will be used and for the enkephalins assay the ELISA Kit for Human Enkephalins ELK5246-96T - Twin Elix srl will be used Neuropeptide assays will be conducted at the Physiology Laboratory of the Department of Chemistry Biology and Biotechnology University of Perugia in collaboration with Prof Fioretti
Sera will also be analyzed for fasting glucose triglycerides TG total cholesterol TC high-density lipoprotein cholesterol HDL insulin dehydroepiandrosterone sulfate DHEAS sex hormone-binding globulin SHBG progesterone estradiol follicle-stimulating hormone FSH LH and total testosterone Serum concentrations of glucose hexokinase total cholesterol CHOD-PAP and triglycerides GPO-PAP will also be measured using standard enzymatic methods Roche Diagnostics IN USA with a fully automated analyzer Roche Modular PE Roche Diagnostics IN USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None