Clinical trial NCT06963840: Effect of Theronomic Ova-All Care on Biomarkers of Ovarian Health in Adult Female With Polycystic Ovarian Syndrome
Official title: Effect of Theronomic Ova-All Care on Biomarkers of Ovarian Health in Adult Female With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Polycystic Ovarian Syndrome (PCOS)
Keywords: probiotic
prebiotic
postbiotic
ovary
menstruation
polycystic ovarian syndrome
Lead sponsor: Wellizen Australia
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. Biomarkers of ovarian health will be measured at baseline, four weeks after the start of the intervention, and at the end of the intervention.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum oestrogen level
timeFrame: From enrollment to end-of intervention (Week 12)
Secondary outcomes:
measure: HbA1c
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Fasting Blood Glucose
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Insulin
timeFrame: From enrollment to end-of intervention (Week 12)
measure: HOMA-IR
timeFrame: From enrollment to end-of intervention (Week 12)
measure: LH
timeFrame: From enrollment to end-of intervention (Week 12)
measure: LH/FSH
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Progesterone
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Testosterone
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Weight
timeFrame: From enrollment to end-of intervention (Week 12)
measure: BMI
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Waist size
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Buttocks size
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Thigh size
timeFrame: From enrollment to end-of intervention (Week 12)
measure: SBP
timeFrame: From enrollment to end-of intervention (Week 12)
measure: DBP
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Total Cholesterol
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Triglycerides
timeFrame: From enrollment to end-of intervention (Week 12)
measure: LDL
timeFrame: From enrollment to end-of intervention (Week 12)
measure: HDL
timeFrame: From enrollment to end-of intervention (Week 12)
measure: hsCRP
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Rotterdam criteria on ultrasound
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Cyst number
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Cyst size
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Endometrial thickness
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Normal ultrasound
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Menstrual cycle length
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Normal menstrual cycle
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Menstruation duration
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Menstrual pain
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Maximal menstrual pain
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Quantity of menstruation
timeFrame: From enrollment to end-of intervention (Week 12)
measure: Ovulation during last cycle
timeFrame: From enrollment to end-of intervention (Week 12)
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Pony Testing Centre
state: Jiangsu
Study officials:
References: