SuitABility
Research type
Research Study
Full title
Investigating the suitability of aniline blue staining for use as a sperm DNA quality assay
IRAS ID
312867
Contact name
Jason Kasraie
Contact email
Sponsor organisation
Shrewsbury and Telford NHS Trust
Duration of Study in the UK
0 years, 6 months, 27 days
Research summary
Research Summary
Sperm cells carry instructions to form a baby in the form of genetic material, called DNA. This DNA contains information which, when combined with complimentary material from an egg, will allow a baby to develop and will determine the baby’s characteristics, such as eye and hair colour. However, the quality of this DNA within a sperm is important. If this material becomes damaged, this can reduce the chances of a healthy baby being born. As such, testing the quality of DNA within sperm is becoming an increasingly used tool for assessing male fertility.
Unfortunately, current sperm DNA quality tests are expensive and have complex protocols. Therefore, this project will investigate a much simpler and cheaper test called aniline blue staining, which assesses how the DNA is packaged within the sperm. The study will use aniline blue staining to test patient samples used during in-vitro fertilisation (IVF) fertility treatment at the Shropshire and Mid Wales Fertility Centre, and the results will be compared to the outcomes of their IVF treatment to establish whether this test produces clinically relevant results. Furthermore, the patient samples will also be tested with two of the more established but complex tests, called the Comet assay and the Sperm Chromatin Structure Assay (SCSA), so the results of aniline blue staining can be directly compared with these tests.
Summary of Results
This study investigated the aniline blue stain, a stain which gives a measure of maturity of sperm cell DNA (the information required from the father to form a baby). A higher aniline blue score was predicted to be linked to lower IVF outcomes, because a higher score would suggest lower quality sperm DNA. The study did not find any significant links between the success of IVF treatment and aniline blue score, although there was surprisingly a slight trend towards a higher aniline blue score resulting in better treatment outcomes. However, ultimately the study could only recruit a small number of participants, so the study was not sufficiently powered to draw this conclusion with any confidence. There does not appear to be a biological mechanism for the slight trend observed so it is likely that with the small study group, other factors influenced the result. A further study with much greater participant numbers is required. This study acted as a good pilot study to show that this kind of study is feasible.
REC name
London - Bromley Research Ethics Committee
REC reference
22/PR/1441
Date of REC Opinion
8 Nov 2022
REC opinion
Further Information Favourable Opinion