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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theronomic Ova-All Care | Experimental | Active treatment - Theronomic Ova-All Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pony Testing Centre | Suzhou | Jiangsu | China |
We will consider sharing IPD upon reasonable request
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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|
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) |
| Rotterdam criteria on ultrasound | Yes/No, must meet at least of the of following criteria on one ovary for "Yes"
| 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) |
| 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 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |