An observational study in Polycystic Ovary Syndrome, sponsored by Albanian University. Recruiting at 1 site in Albania. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Albanian University · Observational
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 50 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →This is the only study on the registry with Albanian University as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Quantify nerve fibers
identify and quantify the nerve fibers in the ovarian stroma and follicles
Time frame: 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).
Time frame: day 0
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.