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Trial Title:
Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)
NCT ID:
NCT05966571
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Procedure
Intervention name:
Ovary Biopsie
Description:
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.
Arm group label:
PCOS women
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.
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.
Criteria for eligibility:
Study pop:
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).
Sampling method:
Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
35 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of medicine of Tirana
Address:
City:
Tirana
Zip:
1000
Country:
Albania
Status:
Recruiting
Contact:
Last name:
Elko Gliozheni, Dr
Phone:
+355692057185
Email:
Elkogliozheni@gmail.com
Contact backup:
Last name:
Orion Gliozheni, Prof
Phone:
+355692029313
Email:
gliozheniorion@gmail.com
Start date:
July 1, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Albanian University
Agency class:
Other
Source:
Albanian University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05966571
