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

NCT06963840 | Active Not Recruiting Phase 2

• 1 other identifier: WEL202501
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Keywords

probiotic; prebiotic; postbiotic; ovary; menstruation; polycystic ovarian syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (35)

• HbA1c

  From enrollment to end-of intervention (Week 12)

• Fasting Blood Glucose

  From enrollment to end-of intervention (Week 12)

• Insulin

  From enrollment to end-of intervention (Week 12)

• HOMA-IR

  From enrollment to end-of intervention (Week 12)

• LH

  From enrollment to end-of intervention (Week 12)

Study Arms (1)

Theronomic Ova-All Care

EXPERIMENTAL

Active treatment - Theronomic Ova-All Care

Dietary Supplement: Theronomic Ova-All Care

Interventions

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.

Theronomic Ova-All Care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wellizen Australia: lead

Study Sites (1)

Pony Testing Centre

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: May 9, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CN (1)