CTRI/2013/02/003431.

Trial name or title	Pre treatment with antioxidants versus no treatment for male partner in couples undergoing assisted reproductive technology (ART) for male infertility: a randomized controlled trial.
Methods	Interventional (clinical trial) Design Randomised: permuted block randomisation, variable method of allocation concealment: sequentially numbered, sealed, opaque envelopes Blinding and masking: open‐label
Participants	Inclusion criteria Couples undergoing ART due to male factor infertility with the following parameters Mild Oligozoospermia 1 to 15 million/mL AND/OR Asthenozoospermia < 32% progressive motility AND/OR Teratozoospermia < 4% normal morphology Exclusion criteria Severe oligozoospermia < 1 million/mL Taken treatment in past 3 months for male infertility Female age > 37 years Female partner ‐ moderate or severe endometriosis
Interventions	Drug: tablet Vitamin C 500 mg, capsule Vitamin E 400 mg and tablet Zinc 140 mg Control: no treatment Duration: 3 months
Outcomes	Primary Clinical pregnancy rate Secondary Ongoing pregnancy rate Miscarriage rate Fertilisation rate Live birth rate Changes in sperm parameters
Starting date	February 2013
Contact information	Dr Mohan S Kamath, MS,DNB, Fellow ( Reproductive Medicine) Associate Professor Reproductive Medicine Unit Christian Medical College and Hospital Vellore 632004 India Telephone: 04162283301 Email: dockamz@gmail.com Affiliation: Christian Medical College and Hospital
Notes	Email sent 26.03.14. Dr Kamath replied 3.04.14 saying that they were still in the recruitment phase and were hoping to finish the trial in 2015. Email sent 07.02.18. Dr Kamath replied 08.02.18 saying that they are still recruiting and hope to complete the recruitment by Mid 2018 and results should be available by the end of 2018. They have recruited approximately 150‐160 participants.