Does taking Impryl (a supplement containing vitamins and micronutrients) reduce levels of homocysteine (a marker of abnormal metabolism) and normalise levels of hormones involved in fertility in women with polycystic ovary syndrome (PCOS)?

Micronutrients in support to the one carbon cycle for the modulation of blood fasting homocysteine in PCOS women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14115156

Enrollment

Registered

2019-10-02

Start date

2017-06-03

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Polycystic ovary syndrome Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome

Interventions

Randomization according to a computer generated list for treatment with the test product or no treatment with a 2:1 ratio to receive the supplement or no treatment for 3 months. The GM

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women referred for gynaecological problems and diagnosed as affected by PCOS according to Rotterdam criteria [Hum Reprod 2004] 2. Aged over 18 years

Exclusion criteria

Exclusion criteria: 1. Ongoing pregnancy 2. Ongoing pharmacological treatment (oral antidiabetic drugs, insulin, antihypertensives, any hormone) 3. Ongoing systemic or endocrine diseases, including hypertension and thyroid diseases

Design outcomes

Primary

Measure	Time frame
Fasting blood homocysteine measured using chemiluminescence before treatment and at the end of the 3-month follow-up	—

Secondary

Measure	Time frame
1. Anti-Mullerian hormone (AMH) measured using ELISA before treatment and at the end of the 3-month follow-up 2. Testosterone measured using an automated immunoassay system before treatment and at the end of the 3-month follow-up 3. Sex hormone-binding globulins (SHBGs) measured using radioimmunoassay (RIA) before treatment and at the end of the 3-month follow-up 4. Free testosterone index (FTI) was calculated using the testosterone and SHGB data before treatment and at the end of the 3-month follow-up	—

Measure

Time frame

1. Anti-Mullerian hormone (AMH) measured using ELISA before treatment and at the end of the 3-month follow-up 2. Testosterone measured using an automated immunoassay system before treatment and at the end of the 3-month follow-up 3. Sex hormone-binding globulins (SHBGs) measured using radioimmunoassay (RIA) before treatment and at the end of the 3-month follow-up 4. Free testosterone index (FTI) was calculated using the testosterone and SHGB data before treatment and at the end of the 3-month follow-up

—

Countries

Italy

Contacts

Public ContactSandro Gerli

sandro.gerli@unipg.it+39 368434624

Outcome results

None listed

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