NCT04836910Not yet recruiting
Microbiome and Polycystic Ovaries
The Change in Microbiome Following Treatment of Women With Polycystic Ovaries
Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS . Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 25 Mar 2021
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Sheba Medical Center
- NCT number
- NCT04836910
What you commit to
- Study type: Observational
- Planned participants: 40
- From 1 Sept 2025 to the primary completion date, 30 Mar 2027
- 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
- Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics/ probiotics, hormonal, vaginal or laxative medicine (in the previous week).
- 4\. Vaginitis/ Pelvic Inflammatory Disease (PID)
Other illness
- Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor).
Who the study is looking for
- Study group: Untreated women diagnosed with PCOS that are planned for intervention.
- Control group: Women without PCOS visiting the gynecologic outpatient's clinics.
Age in the registry: 18 years to 42 years · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.