Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS

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 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.

Conditions

• PCOS

Interventions

DIAGNOSTIC_TEST

Dosage of ematic CGRP

Immunoassay kit for the evaluation of CGRP in blood

DIAGNOSTIC_TEST

Dosage of ematic SP

Immunoassay kit for the evaluation of SP in blood

DIAGNOSTIC_TEST

Dosage of ematic enkephalins

Immunoassay kit for the evaluation of enkephalins in blood

DIAGNOSTIC_TEST

Dosage of ematic VIP

Immunoassay kit for the evaluation of VIP in blood

DIAGNOSTIC_TEST

Dosage of CGRP in follicolar fluid

Immunoassay kit for the evaluation of CGRP in follicolar fluid

DIAGNOSTIC_TEST

Dosage of SP in follicolar fluid

Immunoassay kit for the evaluation of SP in follicolar fluid

DIAGNOSTIC_TEST

Dosage of enkephalins in follicolar fluid

Immunoassay kit for the evaluation of enkephalins in follicolar fluid

DIAGNOSTIC_TEST

Dosage of VIP in follicolar fluid

Immunoassay kit for the evaluation of VIP in follicolar fluid

Sponsors & Collaborators

• University Of Perugia

  lead OTHER

Principal Investigators

• Sandro Gerli, Professor · University Of Perugia

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2025-07-01

Completion

2025-10-01

Countries

• Italy

Study Locations