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Search / Trial NCT05958914

Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS

Launched by UNIVERSITY OF PERUGIA · Jul 20, 2023

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Pcos Neuropeptides Enkephalins Sp Cgrp Vip

ClinConnect Summary

This clinical trial is studying a condition called polycystic ovary syndrome (PCOS) by looking at certain substances in the blood and fluid around the ovaries, known as neuropeptides. Researchers want to understand how these neuropeptides change during different phases of the ovarian cycle in women with and without PCOS. They will compare three groups of women: those with regular menstrual cycles, non-PCOS women undergoing fertility treatment, and women with PCOS also undergoing fertility treatment. The goal is to see if there are differences in neuropeptide levels that could help us better understand PCOS and its effects on fertility.

To be eligible for this study, participants should be infertile women aged between 18 and 40, with a healthy body weight and specific hormone levels. Women with a confirmed diagnosis of PCOS according to established guidelines can also participate. Those who join the trial can expect to provide blood samples at different times during their menstrual cycle and during a fertility treatment procedure. This research is important because it aims to uncover insights that might improve treatment options for women struggling with PCOS and infertility.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About University Of Perugia

The University of Perugia, a prestigious academic institution located in Italy, is dedicated to advancing medical research and clinical innovation through its robust clinical trial initiatives. With a strong emphasis on interdisciplinary collaboration and ethical standards, the university aims to contribute to the development of novel therapeutic strategies and improve patient outcomes. Leveraging its extensive network of healthcare professionals and cutting-edge facilities, the University of Perugia fosters a dynamic research environment that supports both local and international clinical studies, ultimately enhancing the quality of healthcare delivery.

Locations

Perugia, Umbria, Italy

Patients applied

0 patients applied

Trial Officials

Sandro Gerli, Professor

Principal Investigator

University Of Perugia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported