None listed
Conditions
Brief summary
This study is being undertaken to test the hypothesis that the pH of the media used to hold human eggs during IVF treatment can impact fertilisation rates We propose that pH has a profound effect on the assembly and functioning of a component of the egg called the spindle. We have already demonstrated this in mice. We believe that incorrect spindle function can cause lower than expected fertilisation rates, and should fertilisation occur the resulting embryo is of poorer quality. Therefore if pH can effect the spindle, it could have an effect on overall fertilisation. This has significant relevance for the culture systems utilised in IVF clinics worldwide. pH is the term used to describe the balance of acidity (+) and alkalinity (-) of a liquid. The pH scale is from 1-14. If a liquid produces more hydrogen (H+) it is an acid, if it produces more hydroxide (OH-) it is an alkaline. A liquid with a low pH value (less than 7) has lots of hydrogen and is described as acidic, an example of an acidic liquid is lemon juice. A liquid with a high pH value (more than 7) has lots of hydroxide and is described as alkaline, an example of an alkaline substance is bleach or most cleaning products. A liquid which has an equal amount of hydrogen and hydroxide is described as neutral, with a pH of 7. Pure water is usually neutral. The pH inside the human body varies, however the pH of the environment in the ovaries and reproductive tract is slightly alkaline. This is the usual pH of the liquid in which we keep eggs in when they are outside the body. In our laboratory we use media and products from a company called Vitrolife. We will be investigating 2 of their solutions which have been specially manufactured by Vitrolife to be at 2 distinctly different pHs – one at pH 7.2 (the normal pH used in our laboratory), the other will be pH 7.4 (this level is used by some other clinics around the world). We intend to determine which is the optimum pH level to give us the highest rates of fertilisation so that we can try and achieve better results for our patients in the future.
Interventions
This is a prospective randomized controlled study. The population to be included as part of this study will be patients already undergoing (having had cycles previously) or about to commence fertility treatment for the first time at Westmead Fertility Centre.
This study will focus on the oocytes collected from these women following ovarian hyperstimulation, which is part of a normal treatment cycle. We will only analyse oocytes from women who have greater than or equal to 8 eggs collected (so t
This is a prospective randomized controlled study. The population to be included as part of this study will be patients already undergoing (having had cycles previously) or about to commence fertility treatment for the first time at Westmead Fertility Centre. This study will focus on the oocytes collected from these women following ovarian hyperstimulation, which is part of a normal treatment cycle. We will only analyse oocytes from women who have greater than or equal to 8 eggs collected (so that eggs can be randomly assigned to the two different culture pH treatment groups). Patients undergoing either IVF (in vitro fertilisation) or ICSI (intra-cytoplasmic sperm injection) treatment cycles will be considered for this study. The treatment route (IVF vs. ICSI) is predefined in accordance with the Westmead Fertility Centre protocol, and based on a series of tests (semen analyses etc.) before entering into the study. The duration of participation is relatively brief as it will be within their treatment cycle, from the point of egg collection that the study commences, and runs until the fertilisation check (approximately 16-19 hours later). For participants undergoing an IVF cycle, their eggs (in the form of cumulus-oocyte-complexes) will be washed and split evenly between two separate dishes containing different pH G-IVF labelled with A and B. pH of solution A is 7.3 and pH of solution B is 7.45 The eggs will be maintained in the incubator at 37 degrees centigrade and 5 percent CO2 (as standard) until insemination with her partners’ sperm 3-4 hours after egg collection. Insemination will be using 100,000 sperm (as standard) overnight in the incubator. Fertilisation check will be carried out early morning the next day. Results will be recorded in the WFC database initially, then transferred to the results table for this study. For participants undergoing an ICSI cycle, the process differs slightly. After egg collection oocytes will be denuded of their surrounding cumulus cells (as standard), split evenly into two separate dishes containing different pH G-IVF labelled A and B (pH of solution A is 7.3 and pH of solution B is 7.45) and left in the incubator at 37 degrees centigrade and 5 percent CO2 for 1 hour to rest (as standard). After 1 hour, oocytes from dish A will be transferred into ICSI dish A (containing GMOPS media of the same pH, solution A is 7.3 and pH of solution B is 7.45), the spindle will first be visualised and its retardance measured using the Oosight polarised light microscope, before being injected with the partner sperm. The eggs will then be transferred back to a new dish A containing GIVF of the same pH. The same process will be repeated for dish B oocytes. The same embryologist will carry out the ICSI for type A and B eggs. The eggs will then be placed in the incubator overnight to allow for fertilisation. Fertilisation check will be carried out early morning the next day. Results will be recorded in the WFC database initially, then transferred to the results table for this study.
Sponsors
Westmead Fertility Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 41 Years
Healthy volunteers
No
Inclusion criteria
Patients will be asked if they would like to participate if they present for fertility treatment at WFC and fulfil the following: 1) Good understanding/ability of English language to enable them to give an informed consent 2) Less than 42 years old at the time of her treatment cycle 3) Equal to or greater than 8 oocytes collected 4) No more than one prior failed fresh cycle at WFC 5) Heterosexual and same sex couples will be offered to take part
Exclusion criteria
Patients will be excluded from this study if; 1) There is severe male factor infertility requiring sperm extraction via microdissection/open biopsy (PESA/TESA patients can be included) 2) A prior history of poor fertilisation (less than 50 percent oocytes fertilising normally) 3) Oncology patients 4) Unable to speak English without assistance of an interpreter
Outcome results
None listed