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

Last updated: July 28, 2023
Sponsor: Albanian University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

Ovary Biopsie

Clinical Study ID

NCT05966571
1576/prot 1
  • Ages 18-35
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Ovary Biopsie
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • University of medicine of Tirana

    Tirana, 1000
    Albania

    Active - Recruiting

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