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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elko Gliozheni, Dr | Contact | +355692057185 | Elkogliozheni@gmail.com | |
| Bernard Fioretti, Prof | Contact | +393282924573 | bernard.fioretti@unipg.it |
| Name | Affiliation | Role |
|---|---|---|
| Elko Gliozheni, Dr | University of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of medicine of Tirana | Recruiting | Tirana | 1000 | Albania |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |