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. 2017 Jul 28;2017(7):CD007807. doi: 10.1002/14651858.CD007807.pub3
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
Notes