A controlled study to investigate the effect of a food supplement (Femifert™) on polycystic ovarian syndrome and metabolic syndrome in women

Efficacy and tolerability of Femifert™ in women with polycystic ovarian syndrome and metabolic syndrome: a double-blind, randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32169940

Enrollment

Registered

2019-04-23

Start date

2019-05-01

Completion date

Unknown

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovarian syndrome and/or metabolic syndrome Nutritional, Metabolic, Endocrine

Interventions

The study consisted of two intervention treatments: 1. Active treatment (metformin, spironolactone, rosuvastatin, and Femifert™ dietary supplement) 2. Control treatment

standardized to 20% lignans), Ipomea Batatas (80 mg), Lagerstroemia Speciosa (80 mg), Zinc gluconate (50.4 mg), Vitamin B12 (4.5), and Folic Acid (0.6 mg). The daily amount of Femifert™ consumed by p

1 pill). The study is a single-center, double-blind, randomized controlled trial. The intervention model will be a parallel assignment. At least 40 subjects will be randomized to a 24

1 pill) Control Group: Subjects with metabolic syndrome will receive oral pharmacological treatment with metformin, spironolactone, and rosuvastatin. A randomization l

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Age 18-65 3. Triglycerides =150 mg/dl 4. HDL 88cm 8. Index of Ferriman & Gallway score >6 9. Hyperandrogenemia and hyperinsulinemia 10. Presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter, and increased ovarian volume (>10 ml)

Exclusion criteria

Exclusion criteria: 1. Suffer from other causes of hyperandrogenism (e.g. Cushing's syndrome, congenital adrenal hyperplasia, androgen secreting tumors 2. Are pregnant, or suspected to be pregnant 3. History of liver or kidney pathologies 4. History of psychotic illness 5. Present with current and major depression 6 History of cardiovascular diseases 7. Regular consumption of micronutrient and/or herbal and/or polyphenol supplements known to have an impact on insulin sensitivity/secretion and/or vascular/endothelial function

Design outcomes

Primary

Measure	Time frame
Timepoint measures: Baseline (T0); 8 weeks (T1); 16 weeks (T2); 24 weeks (T3): 1. Ovulatory dysfunction, menstrual frequency and variability of cycle length (amenorrhea; dysmenorrhea) measured using menstrual diary data. 2. The Ferriman–Gallwey score (hirsutism) measured using the Ferriman-Gallwey questionnaire. 3. Pelvic ultrasound to measure ovarian volume and number and volume of follicles. 4. Lipid profile (total cholesterol, LDL, HDL, and triglycerides) measured using traditional enzymatic methods. 5. Glycemic and insulinemic index curves. 6. Measurements of: 17-hydroxyprogesterone (17-OHP); sex hormone binding globulin (SHBG); dihydrotestosterone (DHT); 3 alpha-Androstanediol glucuronide (3 alpha diol-G); luteinizing hormone (LH); Follicle-stimulating hormone (FSH); prolactin (PRL); Dehydroepiandrosterone sulfate (DHEA-S); Thyroid-stimulating hormone (TSH) reflex measured using ELISA.	—

Measure

Time frame

Timepoint measures: Baseline (T0); 8 weeks (T1); 16 weeks (T2); 24 weeks (T3): 1. Ovulatory dysfunction, menstrual frequency and variability of cycle length (amenorrhea; dysmenorrhea) measured using menstrual diary data. 2. The Ferriman–Gallwey score (hirsutism) measured using the Ferriman-Gallwey questionnaire. 3. Pelvic ultrasound to measure ovarian volume and number and volume of follicles. 4. Lipid profile (total cholesterol, LDL, HDL, and triglycerides) measured using traditional enzymatic methods. 5. Glycemic and insulinemic index curves. 6. Measurements of: 17-hydroxyprogesterone (17-OHP); sex hormone binding globulin (SHBG); dihydrotestosterone (DHT); 3 alpha-Androstanediol glucuronide (3 alpha diol-G); luteinizing hormone (LH); Follicle-stimulating hormone (FSH); prolactin (PRL); Dehydroepiandrosterone sulfate (DHEA-S); Thyroid-stimulating hormone (TSH) reflex measured using ELISA.

—

Secondary

Measure	Time frame
Timepoint measures: Baseline (T0); 8 weeks (T1); 16 weeks (T2); 24 weeks (T3): 1. Weight, BMI, waist-hip ratio. 2. Polycystic Ovary Syndrome Questionnaire. 3. Treatment safety: liver and kidney function tests and the frequency, severity and nature of adverse events. 4. Adherence to study protocol. 5. Reasons for loss to follow-up.	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026