Analyzing neuropeptide levels in women with and without PCOS during their ovarian cycle
Evaluation of Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS: Pilot Study
This study is testing the levels of certain brain chemicals in women with and without polycystic ovary syndrome (PCOS) during different phases of their menstrual cycle to better understand how PCOS affects fertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University Of Perugia Academic / other |
| Locations | 1 site (Perugia, Umbria) |
| Trial ID | NCT05958914 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the expression of neuropeptides in women with polycystic ovary syndrome (PCOS) compared to women without the condition. It will analyze venous blood samples and follicular fluid during the three phases of the ovarian cycle: follicular, ovulatory, and luteal. The study will enroll 45 patients divided into three groups, with specific focus on neuropeptides such as CGRP, SP, VIP, and enkephalins. The goal is to understand the neurobiological mechanisms underlying PCOS and its impact on fertility.
Who should consider this trial
Good fit: Ideal candidates include infertile women aged 18-30 with regular menstrual cycles and diagnosed with PCOS according to the Rotterdam criteria.
Not a fit: Patients with conditions that prevent oocyte pick-up or those with uncontrolled thyroid disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of PCOS, potentially improving fertility outcomes for affected women.
How similar studies have performed: While studies on neuropeptide expression in relation to PCOS are limited, similar approaches have shown promise in understanding other reproductive disorders.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Perugia, Umbria
- University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte. — Perugia, Umbria, Italy (Recruiting)
Study contacts
- Principal investigator: Sandro Gerli, Professor — University Of Perugia
- Study coordinator: Sandro Gerli, Professor
- Email: sandro.gerli@unipg.it
- Phone: 368434624
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.