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Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)

Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05966571
Enrollment
50
Registered
2023-07-28
Start date
2023-07-01
Completion date
2024-12-01
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Brief summary

Polycystic Ovary Syndrome (PCOS) is a complex endocrine disorder characterized by hyperandrogenism, insulin resistance, and ovulatory dysfunction. One of the diagnostic criteria for PCOS is the presence of polycystic ovaries, which are enlarged ovaries with multiple follicles on ultrasound. However, the mechanisms that lead to the development of polycystic ovaries in PCOS are not completely understood. One potential area of investigation is the role of ovarian innervation in the pathophysiology of PCOS. Therefore, the aim of this study is to evaluate the ovarian innervation in PCOS patients through ovarian biopsy sampling.

Detailed description

This is a cross-sectional study that will involve the recruitment of patients diagnosed with PCOS. The study will be conducted at a tertiary care center Koco Gliozheni Maternity, Faculty of Medicine of Tirana, Department of Obstetrics and Gynecology with expertise in gynecology and endocrinology and will then be examined with the aid of the department of Biology and Physiology of the University of Perugia. The study protocol will be approved by the institutional ethics committee, and written informed consent will be obtained from all participants.

Interventions

PROCEDUREOvary Biopsie

Ovarian biopsy will be performed on patients meeting the inclusion criteria undergoing surgery for other reasons. Ovarian biopsy will be of a few millimeters in size and taken on only one of the ovaries.

Sponsors

Albanian University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of PCOS based on the Rotterdam criteria, * No use of hormonal contraception or medications for at least 3 months prior to the study, * No history of ovarian cancer.

Exclusion criteria

* History of pelvic inflammatory disease or other pelvic infections, * Use of medications that may affect ovarian function or innervation, such as antipsychotics or antidepressants * Presence of ovarian cysts \> 5 cm on ultrasound

Design outcomes

Primary

MeasureTime frameDescription
Quantify nerve fibersday 0identify and quantify the nerve fibers in the ovarian stroma and follicles
Identifying nerual markersday 0Identification of neural markers such as Protein Gene Product 9.5 (PGP 9.5), by useing antibodies (es. neurotransmitters such as tyrosine hydroxylase (TH), vasoactive intestinal peptide (VIP), and neuropeptide Y).

Countries

Albania

Contacts

Primary ContactElko Gliozheni, Dr
Elkogliozheni@gmail.com+355692057185
Backup ContactBernard Fioretti, Prof
bernard.fioretti@unipg.it+393282924573

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026