The use of EmbryoGen in recurrent miscarriage and/or implantation failure patients
The use of EmbryoGen to improve the clinical pregnancy and miscarriage rate in women who have recurrent miscarriage and/or implantation failure
PIVET Medical Centre
100 participants
Feb 1, 2013
Interventional
Conditions
Summary
Approximately 20-40% of all pregnancies end in miscarriage. In patients undergoing IVF treatment for infertility this rate is compounded by a high rate of embryo implantation failure. Based on data collated in the most recent ANZARD report, only 28% of the 50,495 embryo transfer cycles that took place in Australia/ New Zealand in 2008 resulted in a clinical pregnancy, and approximately 1 in 5 of these pregnancies ended in miscarriage. Despite numerous tests available to try and diagnose the cause of miscarriage (mostly involving the genetic diagnosis of chromosomal abnormalities), there are few treatment options available for this patient demographic. EmbryoGen 'Registered Trademark' is the first embryo culture media to show an improved live birth rate in women who have previously experienced miscarriage. We wish to see if this applies to patients undergoing treatment at PIVET Medical Centre
Eligibility
Inclusion Criteria1
- Eligible patients must be 25-45 yrs old and have had greater than or equal to 1 miscarriage or at least three IVF cycles or FET cycles where embryos have failed to implant. They are required to have had at least 1 egg collection at PIVET without the use of EmbryoGen. The data collected from these cycles will act as the control. Patients who have a known reason for the miscarriage such as translocation or uterine pathology (fibroids, polyps) will be excluded.
Exclusion Criteria1
- No history of miscarriage, First IVF cycle, Uterine factors (fibroids, polyps ect.), Translocations, Genetic causes other than aneuploidy
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Interventions
Patients who have had greater than or equal to 1 miscarriage or at least three IVF cycles or FET cycles were embryos have failed to implant will be offered commercially avaliable EmbryoGen 'Registered Trademark' media by there clinician. The patient and partner will be provided with an information sheet and asked to sign a consent form prior to enrollment. They will be made aware of the risks, costs and benefits of the treatment as well as that their individualised IVF treatment plan will not be affected by participating in the trial EmbryoGen 'Registered Trademark' media will be allowed to equilibrate for a minimum of 2 hours in 5-6% CO2 at 37 degrees celsius prior to use. Recover oocytes as usual and prepare sperm according to preferred procedure. Carry out fertilisation (Day 0) in pre- equilibrated EmbryoGen 'Registered Trademark'. Where ICSI is required the sperm injection is performed in pre-equilibrated holding medium. At 16-20 hours (Day 1) after insemination, IVF or ICSI, check for formation of pronuclei, then carefully wash and transfer zygotes to fresh microdrops of EmbryoGen 'Registered Trademark' ( 10 micro litres). Cover with Liquid Paraffin. Embryo transfer at Day 3. Patients will be made aware that they can only have a Day 3 transfer when using EmbryoGen The embryos are prepared and transferred to the uterus in pre- equilibrated EmbryoGen 'Registered Trademark' (e.g. 20 to 30 micro litres). Flush the transfer catheter with EmbryoGen 'Registered Trademark' prior to use. We wish to continue the study until we have 400 oocytes in each arm where the confidence level is 95% and the confidence interval is 5%. Patients can have multiple cycles with EmbryoGen 'Registered Trademark'
Locations(1)
View Full Details on ANZCTR
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ACTRN12612001289808