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)?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: 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 GMP‐manufactured dietary supplement (Impryl, Parthenogen, Switzerland) is in the form of a tablet weighing 1.3 g containing the following nutrients: Betaine 200 mg, L‐cystine 200 mg, niacin 16 mg, zinc 10 mg, vitamin B6 1.4 mg, riboflavin 1.4 mg, folic acid (as methylfolate) 400 microg, vitamin B12 (methylcobalamin) 2.5 µg. Participants will take one tablet per day. CONDITION: Polycystic ovary syndrome ; Nutritional, Metabolic, Endocrine ; Polycystic ovarian syndrome PRIMARY OUTCOME: Fasting blood homocysteine measured using chemiluminescence before treatment and at the end of the 3‐month follow‐up SECONDARY OUTCOME: ; 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; 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
Epistemonikos ID: 3d7fba8e4f435dae37f32a578750c97acc8d1521
First added on: Aug 24, 2024