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Polycystic Ovarian Syndrome (PCOS)Phase 2Ova-All CareNCT06963840

Effect of Theronomic Ova-All Care on Biomarkers of Ovarian Health in Adult Female With Polycystic Ovarian Syndrome

A Phase 2 study testing Theronomic Ova-All Care in people with Polycystic Ovarian Syndrome (PCOS), run by Wellizen Australia at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Theronomic Ova-All Care is a tribiotic health product aimed at improving ovarian health in people with polycystic ovarian syndrome (PCOS). In this study, a total of 16 participants with PCOS diagnosed by a gynaecologist will be invited to take Ova-All Care, two capsule once a day, for 12 weeks. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Polycystic Ovarian Syndrome (PCOS)
What is being tested?
Theronomic Ova-All Care
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
9 May 2025to Aug 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women aged 18-40 years
  • Previous diagnosis of PCOS by a gynaecologist
  • Able to take body temperature every day for 12 weeks
  • Able to attend the testing centre every 4 weeks
  • Able to complete online questionnaires

Who cannot join

  • Pregnancy, lactation;
  • Uterine amenorrhea (such as intrauterine adhesions)
  • Thyroid disease or hyperprolactinemia
  • Liver and kidney dysfunction, autoimmune diseases (such as systemic lupus erythematosus), malignant tumors, mental illness
  • Use of contraceptives, hormone replacement therapy (HRT), immunosuppressants and other drugs that affect ovarian function in the past 3 months.
  • Smokers (>5 cigarettes per day), alcoholics;
  • Unable to cooperate with follow-up or refuse to sign informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Pony Testing Centre

    Suzhou, Jiangsu

Other trials in China

About this study

Theronomic Ova-All Care is a tribiotic health product aimed at improving ovarian health in people with polycystic ovarian syndrome (PCOS). In this study, a total of 16 participants with PCOS diagnosed by a gynaecologist will be invited to take Ova-All Care, two capsule once a day, for 12 weeks. Biomarkers of ovarian health will be measured at baseline, four weeks after the start of the intervention, and at the end of the intervention.

Being tested
Theronomic Ova-All Care
Keywords
probiotic, prebiotic, postbiotic, ovary, menstruation, polycystic ovarian syndrome
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Theronomic Ova-All CareDietary supplement

    Two capsules of Theronomic Ova-All Care, one a day, for 12 weeks. Ova-All Care is a tribiotic, a health product that includes prebiotics, probiotics, and postbiotics. Ova-All Care affects ovarian health by regulating the gut microbiome, which affects oestrogen production and other factors.

Study groups in NCT06963840
Study groupRoleWhat they receive
Theronomic Ova-All CareExperimentalActive treatment - Theronomic Ova-All Care
Receives: Dietary Supplement: Theronomic Ova-All Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum oestrogen level

    Serum oestrogen levels determined by blood test, pg/mL

    We will conduct two subgroup analyses with participants with excessively low (less than 25 pg/mL) and excessively high (more than 138 pg/mL) serum oestrogen levels

    Measured: From enrollment to end-of intervention (Week 12)

Secondary outcomes (35)
  1. HbA1c

    Haemoglobin A1c in percentage.

    We will conduct a subgroup analysis with participants who have an abnormal HbA1c (more than 5.9%) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  2. Fasting Blood Glucose

    Fasting Blood Glucose (FBG), in mmol/L

    We will conduct a subgroup analysis with participants who have an abnormal FBG (more than 6.22 mmol/L) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  3. Insulin

    Serum insulin level, μU/mL.

    We will conduct a subgroup analysis with participants who have an abnormal insulin (more than 24.8 μU/mL) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  4. HOMA-IR

    Homeostatic Model Assessment of Insulin Resistance, no unit.

    We will conduct a subgroup analysis with participants who had abnormal HOMA-IR (more than 2.0) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  5. LH

    Luteinising hormone, in IU/L.

    We will conduct a subgroup analysis with participants who had abnormal LH (more than 11.6) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  6. LH/FSH

    Ratio of luteinising hormone on follicle-stimulating hormone.

    We will conduct a subgroup analysis with participants who had abnormal LH/FSH (more than 2.0) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  7. Progesterone

    Progesterone level, ng/mL.

    We will conduct a subgroup analysis with participants who had abnormal progesterone (more than 2.1) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  8. Testosterone

    Testosterone levels, ng/mL

    We will conduct a subgroup analysis with participants who had abnormal testosterone (more than 0.55 ng/mL) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  9. Weight

    Weight measured by a weight scale, in kg

    We will conduct two subgroup analyses with participants who are overweight (more than 25 kg/m2) and obese (more than 30 kg/m2) at baseline, respectively.

    Measured: From enrollment to end-of intervention (Week 12)

  10. BMI

    Body Mass Index, calculated based on the weight and height, in kg/m2.

    We will conduct two subgroup analyses with participants who are overweight (more than 25 kg/m2) and obese (more than 30 kg/m2) at baseline, respectively.

    Measured: From enrollment to end-of intervention (Week 12)

  11. Waist size

    Waist size measured with a measuring scale, in cm.

    We will conduct a subgroup analyses with participants who had an excessive waist circumference (more than 80 cm) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  12. Buttocks size

    Buttocks size measured with a measuring scale, in cm.

    We will conduct a subgroup analyses with participants who had an excessive buttocks circumference (more than 93 cm) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  13. Thigh size

    Thigh size measured with a measuring scale, in cm.

    Measured: From enrollment to end-of intervention (Week 12)

  14. SBP

    Systolic blood pressure, in mmHg.

    We will conduct a subgroup analyses with participants who had an excessive SBP (more than 120 mmHg) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  15. DBP

    Diastolic blood pressure, in mmHg.

    We will conduct a subgroup analyses with participants who had an excessive DBP (more than 90 mmHg) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  16. Total Cholesterol

    Total cholesterol, in mmol/L.

    We will conduct a subgroup analyses with participants who had an excessive total cholesterol (more than 5.6 mmol/L) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  17. Triglycerides

    Triglycerides, in mmol/L.

    We will conduct a subgroup analyses with participants who had excessive triglycerides (more than 2.3 mmol/L) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  18. LDL

    Low density lipoprotein, in mmol/L.

    We will conduct a subgroup analyses with participants who had an excessive waist circumference (more than 4.11 mmol/L) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  19. HDL

    High density lipoprotein, in mmol/L.

    We will conduct a subgroup analyses with participants who had an excessive HDL (less than 1.15 mmol/L) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  20. hsCRP

    high-specificity C-reactive protein, in mg/L.

    We will conduct a subgroup analyses with participants who had an excessive hsCRP (more than 4 mg/L) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  21. Rotterdam criteria on ultrasound

    Yes/No, must meet at least of the of following criteria on one ovary for "Yes"

    1. ≥20 follicles per ovary, measuring 2-9 mm in diameter, OR
    2. Ovarian volume >10 mL

    Measured: From enrollment to end-of intervention (Week 12)

  22. Cyst number

    Number of cysts measured by ultrasound, in numbers

    Measured: From enrollment to end-of intervention (Week 12)

  23. Cyst size

    Size of the largest cyst, measured by ultrasound, in mm

    Measured: From enrollment to end-of intervention (Week 12)

  24. Endometrial thickness

    Endometrial thickness, measured with ultrasound, in mm

    Measured: From enrollment to end-of intervention (Week 12)

  25. Normal ultrasound

    Normal/abnormal ultrasound, based on the ultrasound report, dichotomous data

    Measured: From enrollment to end-of intervention (Week 12)

  26. Menstrual cycle length

    length of the menstrual cycle, assessed with a tracking app, in days

    Measured: From enrollment to end-of intervention (Week 12)

  27. Normal menstrual cycle

    Dichotomous data Normal = 21-35 Abnormal: more than 35 days or less than 21 days

    Measured: From enrollment to end-of intervention (Week 12)

  28. Menstruation duration

    Menstruation assessed with a self-reported questionnaire, in days

    Measured: From enrollment to end-of intervention (Week 12)

  29. Menstrual pain

    Average level of menstrual pain on a scale of 0 to 10, 10 being the most severe possible pain. No unit.

    Measured: From enrollment to end-of intervention (Week 12)

  30. Maximal menstrual pain

    Maximal level of pain experienced during menstruation, assessed with a participant-reported questionnaire, on a scale of 0 to 10, 10 being the most severe possible pain. No unit.

    Measured: From enrollment to end-of intervention (Week 12)

  31. Quantity of menstruation

    Quantity of blood in the menstruation, assessed with a participant-reported questionnaire, on a Lickert scale with 5 options: too scarce, relatively scarce, normal, relatively abundant and too abundant. In points (0 to 4).

    Measured: From enrollment to end-of intervention (Week 12)

  32. Ovulation during last cycle

    Dichotomous Ovulation: A significant increase in BBT of around 0.3°C to 0.6°C observed between the follicular and luteal phases.

    No ovulation: no bi-phasic feature.

    Measured: From enrollment to end-of intervention (Week 12)

  33. Left ovary volume

    Left ovary volume in mL.

    We will conduct a subgroup analysis with participants who had an abnormal left ovary size (more than 10 mL) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  34. Right ovary volume

    Right ovary volume in mL.

    We will conduct a subgroup analysis with participants who had an abnormal right ovary size (more than 10 mL) at baseline.

    Measured: From enrollment to end-of intervention (Week 12)

  35. Ovulation

    Number of participants who ovulated during their last cycle

    Measured: Baseline to end-of-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start9 May 2025
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06963840
Sponsor's protocol ID
WEL202501
Acronym
Ova-All Care
Status last verified
Aug 2025
First submitted
30 Apr 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will consider sharing IPD upon reasonable request

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Theronomic Ova-All Care in people with Polycystic Ovarian Syndrome (PCOS), run by Wellizen Australia at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum oestrogen level (time frame: From enrollment to end-of intervention (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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