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.
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.
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.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- 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 group | Role | What they receive |
|---|---|---|
| Theronomic Ova-All Care | Experimental | Active 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Thigh size
Thigh size measured with a measuring scale, in cm.
Measured: From enrollment to end-of intervention (Week 12)
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)
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)
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)
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)
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)
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)
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)
Rotterdam criteria on ultrasound
Yes/No, must meet at least of the of following criteria on one ovary for "Yes"
- ≥20 follicles per ovary, measuring 2-9 mm in diameter, OR
- Ovarian volume >10 mL
Measured: From enrollment to end-of intervention (Week 12)
Cyst number
Number of cysts measured by ultrasound, in numbers
Measured: From enrollment to end-of intervention (Week 12)
Cyst size
Size of the largest cyst, measured by ultrasound, in mm
Measured: From enrollment to end-of intervention (Week 12)
Endometrial thickness
Endometrial thickness, measured with ultrasound, in mm
Measured: From enrollment to end-of intervention (Week 12)
Normal ultrasound
Normal/abnormal ultrasound, based on the ultrasound report, dichotomous data
Measured: From enrollment to end-of intervention (Week 12)
Menstrual cycle length
length of the menstrual cycle, assessed with a tracking app, in days
Measured: From enrollment to end-of intervention (Week 12)
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)
Menstruation duration
Menstruation assessed with a self-reported questionnaire, in days
Measured: From enrollment to end-of intervention (Week 12)
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)
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)
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)
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)
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)
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)
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.
- First posted9 May 2025
- Study start9 May 2025
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wellizen Australia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Theronomic Ova-All Care on Biomarkers of Ovarian Health in Adult Female With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT06963840
- Acronym / sponsor ID
- Ova-All Care / WEL202501
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- probiotic, prebiotic, postbiotic, ovary, menstruation, polycystic ovarian syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wellizen AustraliaIndustry (pharma, biotech, devices)
- Study start
- 9 May 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theronomic Ova-All Care | Experimental | Dietary Supplement: Theronomic Ova-All CareActive treatment - Theronomic Ova-All Care |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theronomic Ova-All CareTwo 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. | Dietary supplement | Theronomic Ova-All Care |
Primary outcome
Serum oestrogen level
Time frame: From enrollment to end-of intervention (Week 12)
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
35 secondary outcomes
HbA1c
Time frame: From enrollment to end-of intervention (Week 12)
Fasting Blood Glucose
Time frame: From enrollment to end-of intervention (Week 12)
Insulin
Time frame: From enrollment to end-of intervention (Week 12)
HOMA-IR
Time frame: From enrollment to end-of intervention (Week 12)
LH
Time frame: From enrollment to end-of intervention (Week 12)
LH/FSH
Time frame: From enrollment to end-of intervention (Week 12)
Progesterone
Time frame: From enrollment to end-of intervention (Week 12)
Testosterone
Time frame: From enrollment to end-of intervention (Week 12)
Weight
Time frame: From enrollment to end-of intervention (Week 12)
BMI
Time frame: From enrollment to end-of intervention (Week 12)
Waist size
Time frame: From enrollment to end-of intervention (Week 12)
Buttocks size
Time frame: From enrollment to end-of intervention (Week 12)
Thigh size
Time frame: From enrollment to end-of intervention (Week 12)
SBP
Time frame: From enrollment to end-of intervention (Week 12)
DBP
Time frame: From enrollment to end-of intervention (Week 12)
Total Cholesterol
Time frame: From enrollment to end-of intervention (Week 12)
Triglycerides
Time frame: From enrollment to end-of intervention (Week 12)
LDL
Time frame: From enrollment to end-of intervention (Week 12)
HDL
Time frame: From enrollment to end-of intervention (Week 12)
hsCRP
Time frame: From enrollment to end-of intervention (Week 12)
Rotterdam criteria on ultrasound
Time frame: From enrollment to end-of intervention (Week 12)
Cyst number
Time frame: From enrollment to end-of intervention (Week 12)
Cyst size
Time frame: From enrollment to end-of intervention (Week 12)
Endometrial thickness
Time frame: From enrollment to end-of intervention (Week 12)
Normal ultrasound
Time frame: From enrollment to end-of intervention (Week 12)
Menstrual cycle length
Time frame: From enrollment to end-of intervention (Week 12)
Normal menstrual cycle
Time frame: From enrollment to end-of intervention (Week 12)
Menstruation duration
Time frame: From enrollment to end-of intervention (Week 12)
Menstrual pain
Time frame: From enrollment to end-of intervention (Week 12)
Maximal menstrual pain
Time frame: From enrollment to end-of intervention (Week 12)
Quantity of menstruation
Time frame: From enrollment to end-of intervention (Week 12)
Ovulation during last cycle
Time frame: From enrollment to end-of intervention (Week 12)
Left ovary volume
Time frame: From enrollment to end-of intervention (Week 12)
Right ovary volume
Time frame: From enrollment to end-of intervention (Week 12)
Ovulation
Time frame: Baseline to end-of-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided. We will consider sharing IPD upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.