Gx Media Study
Research type
Research Study
Full title
A sibling oocyte study to investigate the impact on fertility treatment outcomes when using culture media supplemented with antioxidants for preparing eggs and sperm for treatment, at insemination, and during embryo culture.
IRAS ID
336651
Contact name
Bijal Patel
Contact email
Sponsor organisation
LIVERPOOL WOMEN'S NHS FOUNDATION TRUST
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
This sibling oocyte study will involve the preparation, insemination and culture of human gametes and embryos with media featuring additional antioxidants, and comparing the embryo development, utilisation, and clinical pregnancy rates to the standard media used in service. gametes will have their oxidative stress levels assessed prepreparation using the MiOXSYS® system, and the data from this will be collected. Embryos created will be cultured in Embryoscope time-lapse incubators, with the timings of cellular divisions annotated and compared. Aside from the use of an antioxidant media and standard media as the control, gametes and embryos will be treated in accordance with laboratory standard operating procedures.
Aims
The overall aim of this project is to determine whether embryo culture media supplemented with antioxidants improves embryo development and clinical outcomes.
1.Determine if patients with high levels of oxidative stress measured by MiOXSYS® see improved clinical outcomes following gamete preparation and embryo culture in antioxidant media. Improved clinical outcomes will be measured by the following:
a.Comparing blastocyst utilisation rate in the study and control groups against levels of oxidative stress. Use of antioxidant media would be expected to normalise blastocyst utilisation rate in patients measuring high levels of oxidative stress. Blastocyst utilisation rate is a routine KPI measured by the laboratory each month to monitor treatment outcomes. (Blastocyst utilisation = no. of embryos reaching blastocyst cryopreserved or transferred/no. of embryo reaching blastocyst).
b.Measuring the impact of antioxidant media on the timing of embryo development, measured by comparing embryo morphokinetics annotated and obtained from the EmbryoScope™ timelapse incubator between the study and control group. It is expected that the use of antioxidant media will impact cell cycle duration of embryos in culture, with time to t2 (two cell) to time to tsB (time to start of blastulation) decreasing, with an association to improved chance of implantation following embryo transfer.
c. Calculating if the use of antioxidant media improves all the measurable clinical outcomes routinely measured in monthly KPIs: fertilisation rate (no. of oocytes with two pronuclei/no. of oocytes inseminated); embryo morphological quality on day 3 and day 5 (measured by cell number and level of cellular fragmentation); positive test rate (number of positive pregnancy tests/number of embryo transfers); clinical pregnancy rate (number of fetal hearts seen at pregnancy scan/number of embryo transfers); biochemical pregnancy rate (number of scans where no fetal heart seen/number of positive pregnancy tests); and implantation rate (number of fetal hearts seen/number of embryos transferred).2. Determine if patient age, BMI, and cause of infertility, changes the calculated impact when using antioxidant media compared to the control media. Impact of patient characteristics on study outcomes measured by:
a. Comparing blastocyst utilisation rate in the study and control groups between patients under the age of 35 and over the age of 35.
b. Comparing blastocyst utilisation rate in the study and control groups against BMI for patients classed as overweight (>25), normal weight (18.5-24.9) and underweight (<18.5).
c. Comparing blastocyst utilisation rate between the study and control groups in patients with a known causes of infertility such as asthenozoospermia, endometriosis, anovulation.3. Establish if any benefits of antioxidant media are influenced by duration of exposure to ambient oxygen levels when performing egg insemination, outside of the controlled low oxygen environment. During insemination by IVF or ICSI, the duration of the procedure from when oocytes are first removed from their gas-controlled benchtop incubator until they are returned or transferred to the Embryoscope™ timelapse systems.
a.Blastocyst utilisation rate between the study and control groups will be compared against the duration of exposure to atmospheric oxygen during the insemination procedure (1-10 minutes; 11-20 minutes; 21-30 minutes).
REC name
North West - Preston Research Ethics Committee
REC reference
24/NW/0096
Date of REC Opinion
24 May 2024
REC opinion
Further Information Favourable Opinion