Evaluating ovarian innervation in women with Polycystic Ovary Syndrome
Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)
This study is trying to see how the nerves in the ovaries might affect women with Polycystic Ovary Syndrome (PCOS) by taking small samples from their ovaries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Albanian University Academic / other |
| Locations | 1 site (Tirana) |
| Trial ID | NCT05966571 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of ovarian innervation in the pathophysiology of Polycystic Ovary Syndrome (PCOS) by conducting ovarian biopsy sampling in diagnosed patients. It will recruit participants based on the Rotterdam criteria for PCOS and will be conducted at Koco Gliozheni Maternity in Tirana, with collaboration from the University of Perugia for further analysis. The study protocol has received approval from the institutional ethics committee, and informed consent will be obtained from all participants prior to their involvement.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with PCOS who meet the Rotterdam criteria and have not used hormonal contraception or medications affecting ovarian function for at least three months.
Not a fit: Patients with a history of ovarian cancer, pelvic inflammatory disease, or those currently using medications that may influence ovarian function will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of ovarian innervation's role in PCOS, potentially leading to improved diagnostic and therapeutic strategies.
How similar studies have performed: While the specific focus on ovarian innervation in PCOS is relatively novel, similar studies investigating ovarian function and pathology have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tirana
- University of medicine of Tirana — Tirana, Albania (Recruiting)
Study contacts
- Principal investigator: Elko Gliozheni, Dr — University of Medicine
- Study coordinator: Elko Gliozheni, Dr
- Email: Elkogliozheni@gmail.com
- Phone: +355692057185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.