NCT06968455Completed
Endocrine Disruptors, Toxic and Essential Chemical Elements and Polycystic Ovary Syndrome
The Association of Endocrine Disruptors and Toxic and Essential Chemical Elements With Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 13 May 2025
Brief summary (registry, in English)
Studies have shown that endocrine disruptors (EDs) and toxic and essential chemical elements affect women's reproductive health and may play a role in the development of polycystic ovary syndrome (PCOS). There is little research examining the association of EDs and toxic and essential chemical elements with PCOS, and for some chemical compounds there is none. In our study, we will examine the relationship of EDs (bisphenols, parabens, triclosan) and toxic (cadmium-Cd, lead-Pb, mercury-Hg, arsenic-As) and essential chemical elements (selenium-Se, copper-Cu, zinc-Zn, manganum-Mn, molibdenum-Mo) in biological samples (blood, urine) of women with PCOS. Main hypothesis is that the levels of EDs, toxic chemical elements and molibdenum-Mo in the biological samples of PCOS women will be higher, and the levels of essential chemical elements will be lower than in the control group and related to the altered liver and kidney function and to the women's lifestyle and the environment they live in.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 70 (actual)
- First submitted
- 5 May 2025
- Start date
- 3 Jan 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University Medical Centre Ljubljana
- NCT number
- NCT06968455
What you commit to
- Study type: Observational
- Participants enrolled: 70
- From 3 Jan 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- hormonal treatment in the last 3 months (hormonal contraception, hormone replacement therapy, progestogens)
Other illness
- known premature ovarian failure, primary amenorrhea
- chronic diseases: diabetes, depression, Crohn's disease, celiac disease, cardiovascular diseases, liver and kidney disease, asthma, chronic obstructive pulmonary disease, diseases of the musculoskeletal system, neurological diseases, oncological diseases.
Other
- pregnancy
- hyperprolactinemia
- hypothyroidism, hyperthyroidism
Who the study is looking for
- body mass index (BMI) between 18.5 and 29.9 kg/m2
- fulfilling two of the three Rotterdam diagnostic criteria for the diagnosis of PCOS: oligo- or anovulation, ultrasound-visible morphological picture of PCO (presence of 12 or more follicles of size 2-9 mm in one of the ovaries) and/or clinical/biochemical signs of hyperandrogenism (study group)
- a regular menstrual cycle of 21 to 35 days (control group)
Age in the registry: 20 years to 39 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Ob/Gyn, University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.