PCOSPCO-NPNCT05958914
Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS
A study testing Dosage of ematic CGRP, Dosage of ematic SP and Dosage of ematic enkephalins in people with PCOS, run by University Of Perugia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- Dosage of ematic CGRP, Dosage of ematic SP and Dosage of ematic enkephalins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 1 Oct 2025
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertile women
- BMI between 18 and 30 kg/m2,
- basal FSH < 10 IU/L,
- number of antral follicles (2-10 m) per ovary > 10,
- regular uterine cavity assessed by hysterosalpinography, sonohysterography or hysteroscopy, and hematologic and biochemical parameters within normal limits will be included in the study, euthyroid status (with or without treatment)
- In case of women with PCOS, it should be diagnosed according to the Rotterdam criteria (The Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group (2004) Revised 2003 consensus on diagnostic criteria and longterm health risks related to polycystic ovary syndrome (PCOS).
- No restrictions regarding the indication of infertility.
Who cannot join
- presence of ovaries inaccessible to oocyte pick-up,
- presence of sactosalpinx, heterologous fertilization,
- contraindication to pregnancy,
- atypical genital discharge of unspecified cause,
- uncontrolled dystothyroidism, presence of neoplasms,
- severe alteration of liver or kidney function, taking medications that may interfere with the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.
Perugia, Umbria, 06156
Sandro Gerli, MD, +39.075.5783231, sandro.gerli@unipg.it
About this study
Official title: Evaluation of Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS: Pilot Study
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 question[s] it aims to answer are:
Read more
- 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.
Read the 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 chemical/biochemical 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 manufacturer's 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).
- Conditions
- PCOS
- Being tested
- Dosage of ematic CGRP, Dosage of ematic SP, Dosage of ematic enkephalins, Dosage of ematic VIP, Dosage of CGRP in follicolar fluid
- Keywords
- PCOS, neuropeptides, enkephalins, SP, CGRP, VIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage of ematic CGRPDiagnostic test
Immunoassay kit for the evaluation of CGRP in blood
Dosage of ematic SPDiagnostic test
Immunoassay kit for the evaluation of SP in blood
Dosage of ematic enkephalinsDiagnostic test
Immunoassay kit for the evaluation of enkephalins in blood
Dosage of ematic VIPDiagnostic test
Immunoassay kit for the evaluation of VIP in blood
Dosage of CGRP in follicolar fluidDiagnostic test
Immunoassay kit for the evaluation of CGRP in follicolar fluid
Dosage of SP in follicolar fluidDiagnostic test
Immunoassay kit for the evaluation of SP in follicolar fluid
Dosage of enkephalins in follicolar fluidDiagnostic test
Immunoassay kit for the evaluation of enkephalins in follicolar fluid
Dosage of VIP in follicolar fluidDiagnostic test
Immunoassay kit for the evaluation of VIP in follicolar fluid
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | women with regular ovarian cycle. Patients, as per normal clinical practice, will undergo three blood draws in the follicular, ovulatory and luteal phases.
Biological samples will be analyzed for the concentration of neuropeptides (enkephalins, CGRP, SP and VIP) Receives: Diagnostic Test: Dosage of ematic CGRP; Diagnostic Test: Dosage of ematic SP; Diagnostic Test: Dosage of ematic enkephalins; Diagnostic Test: Dosage of ematic VIP |
| Arm 2 | Experimental | non-PCOS women undergoing ovarian stimulation and ICSI treatment. 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.
Biological samples will be analyzed for the concentration of neuropeptides (enkephalins, CGRP, SP and VIP) Receives: Diagnostic Test: Dosage of ematic CGRP; Diagnostic Test: Dosage of ematic SP; Diagnostic Test: Dosage of ematic enkephalins; Diagnostic Test: Dosage of ematic VIP; Diagnostic Test: Dosage of CGRP in follicolar fluid; Diagnostic Test: Dosage of SP in follicolar fluid; Diagnostic Test: Dosage of enkephalins in follicolar fluid; Diagnostic Test: Dosage of VIP in follicolar fluid |
| Arm 3 | Experimental | PCOS women undergoing ovarian stimulation and ICSI treatment. 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.
Biological samples will be analyzed for the concentration of neuropeptides (enkephalins, CGRP, SP and VIP) Receives: Diagnostic Test: Dosage of ematic CGRP; Diagnostic Test: Dosage of ematic SP; Diagnostic Test: Dosage of ematic enkephalins; Diagnostic Test: Dosage of ematic VIP; Diagnostic Test: Dosage of CGRP in follicolar fluid; Diagnostic Test: Dosage of SP in follicolar fluid; Diagnostic Test: Dosage of enkephalins in follicolar fluid; Diagnostic Test: Dosage of VIP in follicolar fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the normal fluctuation of CGRP during the ovarian cycle in non-PCOS women
To evaluate the absolute difference of blood concentration of CGRP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Measured: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
Evaluation of the normal fluctuation of SP during the ovarian cycle in non-PCOS women
To evaluate the absolute difference of blood concentration of SP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Measured: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
Evaluation of the normal fluctuation of VIP during the ovarian cycle in non-PCOS women
To evaluate the absolute difference of blood concentration of VIP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Measured: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
Evaluation of the normal fluctuation of enkephalins during the ovarian cycle of non PCOS women
To evaluate the absolute difference of blood concentration of enkephalins and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Measured: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
Secondary outcomes (20)
Evaluation of the fluctuation of CGRP during the ovarian cycle in non-PCOS women undergoing ICSI treatment
Assess the absolute difference of blood concentration of CGRP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (2-7 days before egg pick-up), ovulatory phase (FO) (on the day of egg pick-up) and luteal phase (FL) (5-10 days after egg pick-up) in non-PCOS women undergoing ovarian stimulation and ICSI treatment (group 2).
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of SP during the ovarian cycle in non-PCOS women undergoing ICSI treatment
Assess the absolute difference of blood concentration of SP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (2-7 days before egg pick-up), ovulatory phase (FO) (on the day of egg pick-up) and luteal phase (FL) (5-10 days after egg pick-up) in non-PCOS women undergoing ovarian stimulation and ICSI treatment (group 2).
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of enkephalins during the ovarian cycle in non-PCOS women undergoing ICSI treatment
Assess the absolute difference of blood concentration of enkephalins and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (2-7 days before egg pick-up), ovulatory phase (FO) (on the day of egg pick-up) and luteal phase (FL) (5-10 days after egg pick-up) in non-PCOS women undergoing ovarian stimulation and ICSI treatment (group 2).
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of VIP during the ovarian cycle in non-PCOS women undergoing ICSI treatment
Assess the absolute difference of blood concentration of VIP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (2-7 days before egg pick-up), ovulatory phase (FO) (on the day of egg pick-up) and luteal phase (FL) (5-10 days after egg pick-up) in non-PCOS women undergoing ovarian stimulation and ICSI treatment (group 2).
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of CGRP during the ovarian cycle in PCOS women undergoing ICSI treatment
Assess the absolute difference in blood concentration of CGRP and the relative difference in its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (2-7 days before oocyte pick-up), ovulatory phase (FO) (on the day of oocyte pick-up) and luteal phase (FL) (5-10 days after oocyte pick-up) in PCOS women undergoing ovarian stimulation procedure and ICSI treatment (group 3).
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of SP during the ovarian cycle in PCOS women undergoing ICSI treatment
Assess the absolute difference in blood concentrations of SP and the relative difference in its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (2-7 days before oocyte pick-up), ovulatory phase (FO) (on the day of oocyte pick-up) and luteal phase (FL) (5-10 days after oocyte pick-up) in PCOS women undergoing ovarian stimulation procedure and ICSI treatment (group 3).
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of enkephalins during the ovarian cycle in PCOS women undergoing ICSI treatment
Assess the absolute difference in blood concentration of enkephalins and the relative difference in its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (2-7 days before oocyte pick-up), ovulatory phase (FO) (on the day of oocyte pick-up) and luteal phase (FL) (5-10 days after oocyte pick-up) in PCOS women undergoing ovarian stimulation procedure and ICSI treatment (group 3).
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of VIP during the ovarian cycle in PCOS women undergoing ICSI treatment
Assess the absolute difference in blood concentration of VIP and the relative difference in its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (2-7 days before oocyte pick-up), ovulatory phase (FO) (on the day of oocyte pick-up) and luteal phase (FL) (5-10 days after oocyte pick-up) in PCOS women undergoing ovarian stimulation procedure and ICSI treatment (group 3).
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of CGRP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment
Comparison of absolute and relative blood concentration of CGRP in the three phases of the ovarian cycle between group 2 (non-PCOS women undergoing ICSI) and group 3 (PCOS women undergoing ICSI), to assess whether, with the same ovulatory condition and treatment, there is increased and significant expression of CGRP in PCOS women compared with non-PCOS women.
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of SP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment
Comparison of absolute and relative blood concentration of SP in the three phases of the ovarian cycle between group 2 (non-PCOS women undergoing ICSI) and group 3 (PCOS women undergoing ICSI), to assess whether, with the same ovulatory condition and treatment, there is increased and significant expression of SP in PCOS women compared with non-PCOS women.
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of enkephalins blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment
Comparison of absolute and relative blood concentration of enkephalins in the three phases of the ovarian cycle between group 2 (non-PCOS women undergoing ICSI) and group 3 (PCOS women undergoing ICSI), to assess whether, with the same ovulatory condition and treatment, there is increased and significant expression of enkephalins in PCOS women compared with non-PCOS women.
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of VIP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment
Comparison of absolute and relative blood concentration of VIP in the three phases of the ovarian cycle between group 2 (non-PCOS women undergoing ICSI) and group 3 (PCOS women undergoing ICSI), to assess whether, with the same ovulatory condition and treatment, there is increased and significant expression of VIP in PCOS women compared with non-PCOS women.
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of CGRP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment
Comparison of absolute and relative blood concentrations of CGRP in the three phases of the ovarian cycle between group 1 (control) and group 2 (non-PCOS women undergoing ICSI tratment), to assess whether, ovarian stimulation represents a modifying factor of neuropeptide expression.
Measured: 7 days after menstruation, 14 days after menstruation, 20 days after menstruation
Comparison of SP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment
Comparison of absolute and relative blood concentrations of SP in the three phases of the ovarian cycle between group 1 (control) and group 2 (non-PCOS women undergoing ICSI tratment), to assess whether, ovarian stimulation represents a modifying factor of neuropeptide expression.
Measured: 7 days after menstruation, 14 days after menstruation, 20 days after menstruation
Comparison of enkephalins blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment
Comparison of absolute and relative blood concentrations of enkephalins in the three phases of the ovarian cycle between group 1 (control) and group 2 (non-PCOS women undergoing ICSI tratment), to assess whether, ovarian stimulation represents a modifying factor of neuropeptide expression.
Measured: 7 days after menstruation, 14 days after menstruation, 20 days after menstruation
Comparison of VIP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment
Comparison of absolute and relative blood concentrations of VIP in the three phases of the ovarian cycle between group 1 (control) and group 2 (non-PCOS women undergoing ICSI tratment), to assess whether, ovarian stimulation represents a modifying factor of neuropeptide expression.
Measured: 7 days after menstruation, 14 days after menstruation, 20 days after menstruation
Comparison of CGRP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment
Evaluate in PCOS and non-PCOS women undergoing ICSI tratment whether CGRP are released into the follicular fluid. If yes, compare absolute and relative concentrations of CGRP between the two groups and assess whether there is a correlation between oocyte quality and neuropeptide dosage.
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of SP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment
Evaluate in PCOS and non-PCOS women undergoing ICSI tratment whether SP are released into the follicular fluid. If yes, compare absolute and relative concentrations of CGRP between the two groups and assess whether there is a correlation between oocyte quality and neuropeptide dosage.
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of enkephalins concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment
Evaluate in PCOS and non-PCOS women undergoing ICSI tratment whether enkephalins are released into the follicular fluid. If yes, compare absolute and relative concentrations of CGRP between the two groups and assess whether there is a correlation between oocyte quality and neuropeptide dosage.
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of VIP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment
Evaluate in PCOS and non-PCOS women undergoing ICSI tratment whether VIP are released into the follicular fluid. If yes, compare absolute and relative concentrations of CGRP between the two groups and assess whether there is a correlation between oocyte quality and neuropeptide dosage.
Measured: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study involves an enrollment of 45 total patients, referred to the Medically assisted reproduction 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
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Gerli, University Of Perugia
- Investigators
- Sandro Gerli, Professor, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958914
- Sponsor's protocol ID
- 27139
- Acronym
- PCO-NP
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
International evidence-based guidelines for the assessment and management of polycystic ovary syndrome 2018. Melbourne, Monash University
Slowey MJ. Polycystic ovary syndrome: new perspective on an old problem. South Med J. 2001 Feb;94(2):190-6.
PubMed 11235033Pasquali R. Metabolic Syndrome in Polycystic Ovary Syndrome. Front Horm Res. 2018;49:114-130. doi: 10.1159/000485995. Epub 2018 Apr 5.
PubMed 29894990Tekin G, Tekin A, Kilicarslan EB, Haydardedeoglu B, Katircibasi T, Kocum T, Erol T, Colkesen Y, Sezgin AT, Muderrisoglu H. Altered autonomic neural control of the cardiovascular system in patients with polycystic ovary syndrome. Int J Cardiol. 2008 Oct 30;130(1):49-55. doi: 10.1016/j.ijcard.2007.08.037. Epub 2007 Dec 4.
PubMed 18055040Sverrisdottir YB, Mogren T, Kataoka J, Janson PO, Stener-Victorin E. Is polycystic ovary syndrome associated with high sympathetic nerve activity and size at birth? Am J Physiol Endocrinol Metab. 2008 Mar;294(3):E576-81. doi: 10.1152/ajpendo.00725.2007. Epub 2008 Jan 15.
PubMed 18198350Morales-Ledesma L, Trujillo Hernandez A, Ramirez MI, Rosas G, Linares R. Administration of a VIP-antagonist in vivo modifies ovarian hormone secretion in a rat model with polycystic ovary syndrome. Life Sci. 2021 Jan 15;265:118792. doi: 10.1016/j.lfs.2020.118792. Epub 2020 Nov 18.
PubMed 33220286Ilie IR. Neurotransmitter, neuropeptide and gut peptide profile in PCOS-pathways contributing to the pathophysiology, food intake and psychiatric manifestations of PCOS. Adv Clin Chem. 2020;96:85-135. doi: 10.1016/bs.acc.2019.11.004. Epub 2019 Dec 12.
PubMed 32362321Moore AM, Campbell RE. Polycystic ovary syndrome: Understanding the role of the brain. Front Neuroendocrinol. 2017 Jul;46:1-14. doi: 10.1016/j.yfrne.2017.05.002. Epub 2017 May 25.
PubMed 28551304Kozlowska A, Wojtkiewicz J, Majewski M, Jana B. Localization of substance P, calcitonin gene related peptide and galanin in the nerve fibers of porcine cystic ovaries. Folia Histochem Cytobiol. 2011;49(4):622-30. doi: 10.5603/fhc.2011.0085.
PubMed 22252756Zhang Z, Gong F, Lu GX. Plasma level of calcitonin gene-related peptide in patients with polycystic ovary syndrome and its relationship to hormonal and metabolic parameters. Peptides. 2012 Apr;34(2):343-8. doi: 10.1016/j.peptides.2012.01.018. Epub 2012 Jan 31.
PubMed 22314079
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS: Pilot Study
- ClinicalTrials.gov ID
- NCT05958914
- Acronym / sponsor ID
- PCO-NP / 27139
- Conditions
- PCOS
- Keywords
- PCOS, neuropeptides, enkephalins, SP, CGRP, VIP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 25 Jul 2023 (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.
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 question[s] 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 chemical/biochemical 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 manufacturer's 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study involves an enrollment of 45 total patients, referred to the Medically assisted reproduction 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Diagnostic Test: Dosage of ematic CGRP, Diagnostic Test: Dosage of ematic SP, Diagnostic Test: Dosage of ematic enkephalins, Diagnostic Test: Dosage of ematic VIPwomen with regular ovarian cycle. Patients, as per normal clinical practice, will undergo three blood draws in the follicular, ovulatory and luteal phases. Biological samples will be analyzed for the concentration of neuropeptides (enkephalins, CGRP, SP and VIP) |
| Arm 2 | Experimental | Diagnostic Test: Dosage of ematic CGRP, Diagnostic Test: Dosage of ematic SP, Diagnostic Test: Dosage of ematic enkephalins, Diagnostic Test: Dosage of ematic VIP, Diagnostic Test: Dosage of CGRP in follicolar fluid, Diagnostic Test: Dosage of SP in follicolar fluid, Diagnostic Test: Dosage of enkephalins in follicolar fluid, Diagnostic Test: Dosage of VIP in follicolar fluidnon-PCOS women undergoing ovarian stimulation and ICSI treatment. 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. Biological samples will be analyzed for the concentration of neuropeptides (enkephalins, CGRP, SP and VIP) |
| Arm 3 | Experimental | Diagnostic Test: Dosage of ematic CGRP, Diagnostic Test: Dosage of ematic SP, Diagnostic Test: Dosage of ematic enkephalins, Diagnostic Test: Dosage of ematic VIP, Diagnostic Test: Dosage of CGRP in follicolar fluid, Diagnostic Test: Dosage of SP in follicolar fluid, Diagnostic Test: Dosage of enkephalins in follicolar fluid, Diagnostic Test: Dosage of VIP in follicolar fluidPCOS women undergoing ovarian stimulation and ICSI treatment. 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. Biological samples will be analyzed for the concentration of neuropeptides (enkephalins, CGRP, SP and VIP) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- infertile women
- BMI between 18 and 30 kg/m2,
- basal FSH < 10 IU/L,
- number of antral follicles (2-10 m) per ovary > 10,
- regular uterine cavity assessed by hysterosalpinography, sonohysterography or hysteroscopy, and hematologic and biochemical parameters within normal limits will be included in the study, euthyroid status (with or without treatment)
Key exclusion criteria (6 listed)
- presence of ovaries inaccessible to oocyte pick-up,
- presence of sactosalpinx, heterologous fertilization,
- contraindication to pregnancy,
- atypical genital discharge of unspecified cause,
- uncontrolled dystothyroidism, presence of neoplasms,
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 |
|---|---|---|
| Dosage of ematic CGRPImmunoassay kit for the evaluation of CGRP in blood | Diagnostic test | Arm 1, Arm 2, Arm 3 |
| Dosage of ematic SPImmunoassay kit for the evaluation of SP in blood | Diagnostic test | Arm 1, Arm 2, Arm 3 |
| Dosage of ematic enkephalinsImmunoassay kit for the evaluation of enkephalins in blood | Diagnostic test | Arm 1, Arm 2, Arm 3 |
| Dosage of ematic VIPImmunoassay kit for the evaluation of VIP in blood | Diagnostic test | Arm 1, Arm 2, Arm 3 |
| Dosage of CGRP in follicolar fluidImmunoassay kit for the evaluation of CGRP in follicolar fluid | Diagnostic test | Arm 2, Arm 3 |
| Dosage of SP in follicolar fluidImmunoassay kit for the evaluation of SP in follicolar fluid | Diagnostic test | Arm 2, Arm 3 |
| Dosage of enkephalins in follicolar fluidImmunoassay kit for the evaluation of enkephalins in follicolar fluid | Diagnostic test | Arm 2, Arm 3 |
| Dosage of VIP in follicolar fluidImmunoassay kit for the evaluation of VIP in follicolar fluid | Diagnostic test | Arm 2, Arm 3 |
Primary outcome
Evaluation of the normal fluctuation of CGRP during the ovarian cycle in non-PCOS women
Time frame: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
To evaluate the absolute difference of blood concentration of CGRP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Evaluation of the normal fluctuation of SP during the ovarian cycle in non-PCOS women
Time frame: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
To evaluate the absolute difference of blood concentration of SP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Evaluation of the normal fluctuation of VIP during the ovarian cycle in non-PCOS women
Time frame: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
To evaluate the absolute difference of blood concentration of VIP and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Evaluation of the normal fluctuation of enkephalins during the ovarian cycle of non PCOS women
Time frame: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
To evaluate the absolute difference of blood concentration of enkephalins and the relative difference of its concentration [100 - (CFO*100/CFF) and 100 - (CFL*100/CFO)] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
20 secondary outcomes
Evaluation of the fluctuation of CGRP during the ovarian cycle in non-PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of SP during the ovarian cycle in non-PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of enkephalins during the ovarian cycle in non-PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of VIP during the ovarian cycle in non-PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of CGRP during the ovarian cycle in PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of SP during the ovarian cycle in PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of enkephalins during the ovarian cycle in PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Evaluation of the fluctuation of VIP during the ovarian cycle in PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of CGRP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of SP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of enkephalins blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of VIP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of CGRP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment
Time frame: 7 days after menstruation, 14 days after menstruation, 20 days after menstruation
Comparison of SP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment
Time frame: 7 days after menstruation, 14 days after menstruation, 20 days after menstruation
Comparison of enkephalins blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment
Time frame: 7 days after menstruation, 14 days after menstruation, 20 days after menstruation
Comparison of VIP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment
Time frame: 7 days after menstruation, 14 days after menstruation, 20 days after menstruation
Comparison of CGRP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of SP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of enkephalins concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Comparison of VIP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment
Time frame: 5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- BackgroundInternational evidence-based guidelines for the assessment and management of polycystic ovary syndrome 2018. Melbourne, Monash University
- Background: PubMed 11235033Slowey MJ. Polycystic ovary syndrome: new perspective on an old problem. South Med J. 2001 Feb;94(2):190-6.
- Background: PubMed 29894990Pasquali R. Metabolic Syndrome in Polycystic Ovary Syndrome. Front Horm Res. 2018;49:114-130. doi: 10.1159/000485995. Epub 2018 Apr 5.
- Background: PubMed 18055040Tekin G, Tekin A, Kilicarslan EB, Haydardedeoglu B, Katircibasi T, Kocum T, Erol T, Colkesen Y, Sezgin AT, Muderrisoglu H. Altered autonomic neural control of the cardiovascular system in patients with polycystic ovary syndrome. Int J Cardiol. 2008 Oct 30;130(1):49-55. doi: 10.1016/j.ijcard.2007.08.037. Epub 2007 Dec 4.
- Background: PubMed 18198350Sverrisdottir YB, Mogren T, Kataoka J, Janson PO, Stener-Victorin E. Is polycystic ovary syndrome associated with high sympathetic nerve activity and size at birth? Am J Physiol Endocrinol Metab. 2008 Mar;294(3):E576-81. doi: 10.1152/ajpendo.00725.2007. Epub 2008 Jan 15.
- Background: PubMed 33220286Morales-Ledesma L, Trujillo Hernandez A, Ramirez MI, Rosas G, Linares R. Administration of a VIP-antagonist in vivo modifies ovarian hormone secretion in a rat model with polycystic ovary syndrome. Life Sci. 2021 Jan 15;265:118792. doi: 10.1016/j.lfs.2020.118792. Epub 2020 Nov 18.
- Background: PubMed 32362321Ilie IR. Neurotransmitter, neuropeptide and gut peptide profile in PCOS-pathways contributing to the pathophysiology, food intake and psychiatric manifestations of PCOS. Adv Clin Chem. 2020;96:85-135. doi: 10.1016/bs.acc.2019.11.004. Epub 2019 Dec 12.
- Background: PubMed 28551304Moore AM, Campbell RE. Polycystic ovary syndrome: Understanding the role of the brain. Front Neuroendocrinol. 2017 Jul;46:1-14. doi: 10.1016/j.yfrne.2017.05.002. Epub 2017 May 25.
- Background: PubMed 22252756Kozlowska A, Wojtkiewicz J, Majewski M, Jana B. Localization of substance P, calcitonin gene related peptide and galanin in the nerve fibers of porcine cystic ovaries. Folia Histochem Cytobiol. 2011;49(4):622-30. doi: 10.5603/fhc.2011.0085.
- Background: PubMed 22314079Zhang Z, Gong F, Lu GX. Plasma level of calcitonin gene-related peptide in patients with polycystic ovary syndrome and its relationship to hormonal and metabolic parameters. Peptides. 2012 Apr;34(2):343-8. doi: 10.1016/j.peptides.2012.01.018. Epub 2012 Jan 31.
- Individual participant dataSharing planned: No
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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.
Sandro Gerli, Professor principal investigator
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosage of ematic CGRP, Dosage of ematic SP and Dosage of ematic enkephalins in people with PCOS, run by University Of Perugia at 1 site in Italy.
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 7 inclusion and 6 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 25 Jul 2023. 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 Italy. 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 Sandro Gerli, Professor (368434624, sandro.gerli@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the normal fluctuation of CGRP during the ovarian cycle in non-PCOS women (time frame: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual). The study lists 4 primary outcomes in all. 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 NCT05958914, which also lists 10 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 25 Jul 2023.