ORP and ART
Research type
Research Study
Full title
Diagnostic accuracy of oxidation-reduction potential in predicting outcomes of Assisted Conception treatment
IRAS ID
246383
Contact name
Neelam Potdar
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
For infertility investigations and treatment, a semen analysis is performed to determine the sperm quality. Fundamental information about sperm is obtained through assessing sperm concentration, motility and morphology. Whilst these parameters provide baseline information about a male’s fertility and influence treatment options, they do not provide any information about sperm function at molecular level. Increase in seminal oxidative stress can impair sperm DNA function however this aspect of sperm function in not routinely assessed.
Intrauterine insemination (IUI) is the recommended fertility treatment for unexplained subfertility and mild male factor subfertility, whilst in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) is appropriate for couples with tubal factor or significant male factor subfertility. Little is known about the effect of seminal oxidative stress on fertility treatment outcomes. It is possible that high levels of oxidative stress are associated with poor outcomes of fertility treatments such as reduced fertilisation rates, embryo development and less chance of pregnancy. This study is aimed to measure oxidative stress in semen samples of couples undergoing fertility treatment and correlate with the treatment outcomes.
Participants will be patients having fertility treatment at Leicester Fertility Centre. As part of their routine treatment, patients provide a semen sample. The surplus of this sample will be assessed for oxidative stress levels by measuring the oxidative-reduction potential (ORP) and sperm DNA fragmentation (SDF). Participants will also provide a blood sample on the day of treatment for measuring the blood oxidative stress levels.
As part of routine care, participants will have treatment and follow-up care which includes a pregnancy test and subsequent ultrasound scan to check for pregnancy.Summary of Results
For infertility investigations and treatment, a semen analysis is performed to determine the sperm quality. Fundamental information about sperm is obtained through assessing sperm concentration, motility and morphology. Whilst these parameters provide baseline information about a male’s fertility and influence treatment options, they do not provide any information about sperm function at molecular level. Increase in seminal oxidative stress can impair sperm DNA function however this aspect of sperm function in not routinely assessed. Intrauterine insemination is the recommended fertility treatment for unexplained subfertility and mild male factor subfertility, whilst in-vitro fertilisation and intracytoplasmic sperm injection is appropriate for couples with tubal factor or significant male factor subfertility. Little is known about the effect of seminal oxidative stress on fertility treatment outcomes. It is possible that high levels of oxidative stress are associated with poor outcomes of fertility treatments such as reduced fertilisation rates, embryo development and less chance of pregnancy. This study is aimed to measure oxidative stress in semen samples of couples undergoing fertility treatment, and patient experiencing recurrent miscarriage and correlate with the treatment outcomes. Participants were patients having fertility treatment at Leicester Fertility Centre. As part of their routine treatment, patients provide a semen sample. The surplus of this sample will be assessed for oxidative stress levels by measuring the oxidative-reduction potential. Participants will also provide a blood sample on the day of treatment for measuring the blood oxidative stress levels. As part of routine care, participants will have treatment and follow-up care which includes a pregnancy test and subsequent ultrasound scan to check for pregnancy.The primary research question was to:
1. Examine the relationship between seminal ORP concentrations and clinical pregnancy rates (CPR) in couples undergoing intrauterine insemination, in-vitro fertilisation and intracytoplasmic sperm injection treatment for idiopathic/mild male factor subfertility.The secondary research questions were to:
1. Correlate seminal and blood ORP for the same participant on samples taken on the day of the fertility treatment.
2. Correlate seminal ORP concentrations with sperm DNA damage rates in same semen sample (percentage DNA fragmentation index).
3. Correlate seminal ORP concentrations in IVF and ICSI cycles with laboratory outcomes of fertilisation rates, cleavage rates and embryo development.The study incurred delays due to equipment validation errors and due to COVID-19. This impacted the sample size for patient undergoing ‘Recurrent Miscarriage’ and ‘Sperm DNA Fragmentation’ (this cohort of patient were removed from the study analysis).The results of the demonstrate that a lower reference value to predict ‘normal and abnormal’ samples applies to the study population of the East Midlands. The studied showed that using oxidation-reduction potential as a predictor of treatment outcomes was poor for all three recommended treatments. With future research and potentially a larger study population, the study may help contribute to understanding aspects of male factor infertility. Following the study, the results will be further analysed and potential published.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/1243
Date of REC Opinion
13 Jul 2018
REC opinion
Further Information Favourable Opinion