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

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Procedure: Ovary Biopsie

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Elko Gliozheni, Dr; Phone Number: +355692057185; Email: Elkogliozheni@gmail.com
• Study Contact Backup: Name: Bernard Fioretti, Prof; Phone Number: +393282924573; Email: bernard.fioretti@unipg.it

Study Locations

• Albania
  • Tirana, Albania, 1000
    • Recruiting
    • University of Medicine of Tirana
    • Contact: Elko Gliozheni, Dr; Phone Number: +355692057185; Email: Elkogliozheni@gmail.com
    • Contact: Orion Gliozheni, Prof; Phone Number: +355692029313; Email: gliozheniorion@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

PCOS Patients who meet the inclusion criteria will undergo a detailed medical history, physical examination, and laboratory investigations including hormonal evaluation as necessary (testosterone, sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone, prolactin, thyroid-stimulating hormone, and cortisol).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCOS women; Ovarian biopsy will be performed on PCOS women meeting the inclusion criteria undergoing surgery for other reasons . A sample of the ovarian tissue will be of a few millimeters in size and taken on only one of the ovaries.	Procedure: Ovary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify nerve fibers	identify and quantify the nerve fibers in the ovarian stroma and follicles	day 0
Identifying nerual markers	Identification 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).	day 0

Collaborators and Investigators

• Sponsor: Albanian University
• Investigators: Principal Investigator: Elko Gliozheni, Dr, University of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: 1576/prot 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No