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NCT Number: NCT06963840

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pony Testing Centre

Suzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Theronomic Ova-All Care

Dietary 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. HbA1c

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

    Haemoglobin A1c in percentage.

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

  2. Fasting Blood Glucose

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

    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.

  3. Insulin

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

    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.

  4. HOMA-IR

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

    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.

  5. LH

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

    Luteinising hormone, in IU/L.

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

  6. LH/FSH

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

    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.

  7. Progesterone

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

    Progesterone level, ng/mL.

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

  8. Testosterone

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

    Testosterone levels, ng/mL

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

  9. Weight

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

    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.

  10. BMI

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

    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.

  11. Waist size

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

    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.

  12. Buttocks size

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

    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.

  13. Thigh size

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

    Thigh size measured with a measuring scale, in cm.

  14. SBP

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

    Systolic blood pressure, in mmHg.

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

  15. DBP

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

    Diastolic blood pressure, in mmHg.

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

  16. Total Cholesterol

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

    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.

  17. Triglycerides

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

    Triglycerides, in mmol/L.

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

  18. LDL

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

    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.

  19. HDL

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

    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.

  20. hsCRP

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

    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.

  21. Rotterdam criteria on ultrasound

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

    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

  22. Cyst number

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

    Number of cysts measured by ultrasound, in numbers

  23. Cyst size

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

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

  24. Endometrial thickness

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

    Endometrial thickness, measured with ultrasound, in mm

  25. Normal ultrasound

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

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

  26. Menstrual cycle length

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

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

  27. Normal menstrual cycle

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

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

  28. Menstruation duration

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

    Menstruation assessed with a self-reported questionnaire, in days

  29. Menstrual pain

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

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

  30. Maximal menstrual pain

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

    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.

  31. Quantity of menstruation

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

    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).

  32. Ovulation during last cycle

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

    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.

  33. Left ovary volume

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

    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.

  34. Right ovary volume

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

    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.

  35. Ovulation

    Time frame: Baseline to end-of-intervention

    Number of participants who ovulated during their last cycle

Sponsors and collaborators

Lead sponsor

Wellizen Australia

Industry

Registry information

Acronym: Ova-All Care

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 9, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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