Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial).
Level 5 - mechanism / opinion, no new human data
Clinical trial protocol without empirical outcome data
PubMed 32616489 · doi:10.1136/bmjopen-2019-035069
What was done
This paper describes the protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial (the SUMMER trial). The study aims to enrol 1,200 men aged 18–50 years whose partners are diagnosed with infertility and receiving expectant management, intrauterine insemination (IUI), in vitro fertilisation (IVF), or intracytoplasmic sperm injection (ICSI). Participants are randomised to receive daily oral tablets of the nutritional supplement Impryl or identical placebo for up to 6 months. The primary outcome is ultrasound-confirmed ongoing pregnancy at 10 to 12 weeks conceived within 6 months of randomisation.
What was found
As a study protocol, this paper reports no clinical outcome data or results.
Why it matters
Oxidative stress is implicated in a large proportion of male infertility cases. This trial protocol details the methodology of an adequately powered randomized evaluation to determine whether targeted metabolic supplementation improves ongoing pregnancy rates.
Limits
This publication contains only the trial design and presents no outcome data. The study population includes couples undergoing diverse fertility management approaches ranging from expectant management to ICSI, which may introduce clinical heterogeneity.
Cited by
- supports The human sperm turnover cycle is approximately 3 months.