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

NCT05966571 | Unknown

• 1 other identifier: 1576/prot 1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Ovary Biopsie PROCEDURE

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.

PCOS women

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albanian University: lead

Study Sites (1)

University of medicine of Tirana

Tirana, 1000, Albania

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Elko Gliozheni, Dr

  University of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elko Gliozheni, Dr

CONTACT

+355692057185; Elkogliozheni@gmail.com

Bernard Fioretti, Prof

CONTACT

+393282924573; bernard.fioretti@unipg.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

AL (1)