| Methods | Randomised controlled trial | |
| Participants | Infertile couples with unexplained infertility seeking ICSI/IVF treatment following at least 3 failed previous IUI cycles (n = 218). Mean age Treatment group: 30.9 years; Control group: 30.6 Inclusion criteria: women aged < 40 years with normal ovulatory cycles, normal baseline; FSH 12 IU/l, thyroid‐stimulating hormone, prolactin levels, tubal patency at hysterosalpingography, normal transvaginal ultrasound scan, presence of both ovaries and normal findings at laparoscopy. All male partners had a normal semen analysis by WHO criteria Exclusion criteria: Couples who had received any form of vitamin supplementation for a period of 3 months before start of treatment |
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| Interventions | Women in both groups received a daily dose of 2.5 mg of folic acid. 1. OCTATRON ® NERHADOU INTERNATIONAL (composition; vitamin A 3000 IU; d‐alpha tocopheryl acid; (vitamin E) 15 IU; ascorbic acid (vitamin C) 90 mg; Zinc (amino acid‐chelated) 11 mg; molybdenum (amino acid chelated) 45 μg; selenium (amino acid chelated) 55 μg, biotin 10 μg and mixed bioflavonoid 100 mg): 1 capsule a day (n= 112) 2. Folic acid 2.5 mg: 1 tablet a day (n = 106) Treatment was for 2½ months 7 women lost from each arm with explanation |
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| Outcomes | The primary outcome was the number of mature oocytes Secondary outcomes were clinical pregnancy rate, defined as appearance of intrauterine gestational sac with fetal heart pulsation at 7 weeks Fertilisation rate Number of embryos transferred and cryopreserved Multiple pregnancy rate Early miscarriage rate Duration of stimulation Amount of FSH |
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| Notes | Cairo Egypt Trial ran from February 2011 to March 2013 "On pregnancy confirmation, both groups received antioxidant and folic acid supplementation during the first trimester with follow‐up in accordance with this canter ’s policy. Participants ’ compliance with treatment, that is, the intake of supplements was confirmed and recorded on each visit by the caring physicians". This paper is the published version of Aboulfoutouh 2011 in first version of the review Email and letter sent to authors 9th August 2012asking about types of antioxidants used and ITT in the pregnancy outcome. Authors replied with data information. Participants were followed up only to clinical pregnancy, so no live birth data are provided |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "We developed computer generated list for randomization" from an email received 12th December 2015 |
| Allocation concealment (selection bias) | Low risk | "used closed opaque envelops for concealment by third party nurse" from an email received 12th December 2015 |
| Blinding (performance bias and detection bias) All outcomes | High risk | No blinding, control is no treatment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition explained |
| Selective reporting (reporting bias) | Low risk | Outcomes reported. Protocol available |
| Other bias | Low risk | No other bias found |
17B‐E2: 17B estradiol
ASRM: American Society for Reproductive Medicine
BMI: body mass index
CC: clomiphene citrate
ESHRE: European Society for Human Reproduction and Embryology
FSH: follicle stimulating hormone
GnRH: gonadotropin releasing hormone
hCG: human chorionic gonadotropin
HSG: hysterosalpingography
ICSI: intracytoplasmic sperm injection
ITT: intention‐to‐treat
IVF: in vitro fertilisation
MDA: malondialdehyde
NAC: N‐acetylcysteine
OC: oral contraceptive
OHSS: ovarian hyperstimulation syndrome
PCOS: poly cystic ovarian syndrome
rFSH: recombinant follicle stimulating hormone
SD: standard deviation
WHO: World Health Organization