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

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 Overview

• Status: Active, not recruiting
• Conditions: Polycystic Ovarian Syndrome (PCOS)
• Intervention / Treatment: Dietary supplement: Theronomic Ova-All Care

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Pony Testing Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

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

Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Theronomic Ova-All Care; Active treatment - Theronomic Ova-All Care	Dietary supplement: Theronomic Ova-All Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to end-of intervention (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to end-of intervention (Week 12)
Cyst number	Number of cysts measured by ultrasound, in numbers	From enrollment to end-of intervention (Week 12)
Cyst size	Size of the largest cyst, measured by ultrasound, in mm	From enrollment to end-of intervention (Week 12)
Endometrial thickness	Endometrial thickness, measured with ultrasound, in mm	From enrollment to end-of intervention (Week 12)
Normal ultrasound	Normal/abnormal ultrasound, based on the ultrasound report, dichotomous data	From enrollment to end-of intervention (Week 12)
Menstrual cycle length	length of the menstrual cycle, assessed with a tracking app, in days	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	From enrollment to end-of intervention (Week 12)
Menstruation duration	Menstruation assessed with a self-reported questionnaire, in days	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.	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.	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).	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.	From enrollment to end-of intervention (Week 12)
HbA1c	Haemoglobin A1c in percentage. We will conduct a subgroup analysis with participants who have an abnormal HbA1c (more than 5.9%) at baseline.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From enrollment to end-of intervention (Week 12)
Thigh size	Thigh size measured with a measuring scale, in cm.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From enrollment to end-of intervention (Week 12)
Ovulation	Number of participants who ovulated during their last cycle	Baseline to end-of-intervention

Collaborators and Investigators

• Sponsor: Wellizen Australia

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 30, 2025
• First Submitted That Met QC Criteria: April 30, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: prebiotic; probiotic; ovary; postbiotic; polycystic ovarian syndrome; menstruation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome
• Other Study ID Numbers: WEL202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will consider sharing IPD upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No