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Studies gut and vaginal bacteria in women with polycystic ovaries during treatment

Observes bacteria in the gut and vagina of women with polycystic ovary syndrome during treatment.

Key facts

Who runs it
Sheba Medical Center
Where
Ramat Gan, IsraelSee the site
Trial code
Registry title
Microbiome and Polycystic Ovaries
Status
Not yet recruiting
People taking part
40 people, planned
Started
1 Sept 2025
Expected to end
30 Mar 2027
Type of study
Observational, 2 groups
Treatments tested
  • Dietary recommendations
  • Oral contraceptive pills
  • Metformin
Record updated
14 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 to 42. One group has untreated polycystic ovary syndrome (PCOS) and a planned treatment. The other group has no PCOS.

Age
18 to 42 years
Sex
Women only
Disease stage
Study group: untreated women with PCOS who are planned for treatment. Control group: women without PCOS who visit gynecologic outpatient clinics.
Earlier treatment
Women with PCOS must be untreated. Women who took antibiotics, probiotics, hormonal, vaginal or laxative medicine in the previous week cannot join.

Main reasons for not taking part

  • Another hormone problem, such as Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia or an androgen-secreting tumor
  • Premature ovarian failure
  • Active cancer
  • Antibiotics, probiotics, hormonal, vaginal or laxative medicine in the previous week
  • Vaginitis or pelvic inflammatory disease (PID)

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Study group: Untreated women diagnosed with PCOS that are planned for intervention
  • Control group: Women without PCOS visiting the gynecologic outpatient's clinics

Who cannot take part

  • Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics/ probiotics, hormonal, vaginal or laxative medicine (in the previous week)
  • Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor)
  • Vaginitis/ Pelvic Inflammatory Disease (PID)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 42 years old?

Where in Israel

  • Sheba medical centerRamat Gan, IsraelContact: Aya SassonNo longer taking part

About the trial

What the trial wants to find out

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 .

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Study Group: Women with Polycystic Ovary Syndrome

    Woen diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Criteria (requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen. 2. Oligo or anovulation. 3. Polycystic ovaries on ultrasound - over 12 follicles, 2-9 mm or increased ovarian volume),who haven't started any treatment

    Treatment: Dietary recommendations, Oral contraceptive pills, and Metformin

  • Cohort Group: Women without Polycystic Ovary Syndrome

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Change in Microbiome Following Treatment of Women With Polycystic Ovaries
Plain-language title
Studies gut and vaginal bacteria in women with polycystic ovaries during treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04836910, who can take part
Record updated
14 November 2024