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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966571
• Other study ID #: 1576/prot 1
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Albanian University
• Contact: Elko Gliozheni, Dr
• Phone: +355692057185
• Email: Elkogliozheni[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Albania	University of medicine of Tirana	Tirana

Sponsors (1)

Lead Sponsor	Collaborator
Albanian University

Country where clinical trial is conducted

Albania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify nerve fibers	identify and quantify the nerve fibers in the ovarian stroma and follicles	day 0
Primary	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