CTRI/2012/08/002943

Trial name or title	Nutritional supplement for women With polycystic ovary syndrome or subfertilty
Methods	Randomised, parallel‐group, placebo‐controlled trial Method of generating randomisation sequence: computer‐generated randomisation Method of allocation concealment: pre‐numbered or coded identical Containers blinding and masking: participant‐ and investigator‐blinded
Participants	Inclusion criteria: Women between 18 and 38 years of age with PCOS Presence of any 2 of the following parameters: (Roterdam criteria 2003) Oligomenorrhoea and/or anovulation; Hyperandrogenism (clinical and/or biochemical) (Ferriman‐Gallwey score > 8); biological (luteinising hormone (LH)/FSH ratio > 2). OR Subfertile women; Sexually active and male partner with potential to produce a child; Polycystic ovaries with exclusion of other aetiologies; Women with normal uterine cavity; Participants with impaired glucose tolerance or insulin resistance; Normal physical activity confirmed by physical and clinical examination, and routine laboratory tests, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), haematology, routine urinalysis and measurement of oral temperature and vital signs.
Interventions	Intervention 1: multiple micronutrients supplementation: 1 Formula A tablet + 1 Formula B tablet together after main meal twice a day for 4 months Ingredients Formula A: N‐acetyl L‐cysteine, elemental magnesium, zinc, iron, manganese, copper, selenium, iodine, chromium. Ingredients Formula B: inositol, vitamin C, para‐amino‐benzoic acid, vitamin E acetate, L‐arginine, D‐chiro‐inositol, vitamin B complex Control intervention 1: placebo tablets for Formula A: 1 tablet after main meal twice a day for 4 months Control intervention 2: placebo tablets for Formula B: 1 tablet after main meal twice a day for 4 months
Outcomes	Improvement in overall status of PCOS or infertility. Timepoint: days 30, 60, 90 and 120. Improvement in different parameters defining the status of PCOS or infertility‐like hormonal levels, insulin resistance, weight and safety of the therapy Timepoint: days 30, 60, 90 and 120
Starting date	31 August 2012
Contact information	Dr Yashwant Mane Dr Yashwant Mane Atharva Infertilty and Test Tube Baby Center Jagir Complex Dwarka, Nasik, India 422011 Nashik, MAHARASHTRA India ph 02532598953 email drysmane7473@yahoo.co.in
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