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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05966571
Other study ID # 1576/prot 1
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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