None listed
Conditions
Brief summary
At Genea frozen embryo transfer pregnancy success rates have improved to a level close to fresh embryo transfer success rates. The embryos used in the frozen cycles are the second and third best embryos - as graded for development rate and morphology- compared to the embryos transferred in the fresh cycles when the best quality embryo is selected for transfer to the uterus. The hormone stimulation undertaken prior to oocyte collection may affect the endometrium (uterine lining) - advancing it to a stage whereby the embryo implantation prospect could be impaired and therefore reducing the chance of an ongoing pregnancy. The hypothesis is that freezing of all embryos may help to overcome any reduction in implantation potential by allowing improved synchronisation between the embryo and the endometrium, leading to both higher implantation and pregnancy rates. There are a number of causes of pregnancy failure following IVF treatment including genetically abnormal embryos, poor quality embryos and potentially a non-receptive uterine environment. The transfer of genetically and morphologically normal embryos into a non-receptive uterine environment will likely not achieve a pregnancy. Generally the suitability of the uterine environment is measured by ultrasound. However such measurement is not able to provide full information on how the uterus has developed under the influence of hormone stimulation drugs used routinely in an IVF treatment cycle. Genea has extensive experience with vitrification technology having been the first clinic to introduce the procedure into routine clinical practise in Australia, January 2006. Subsequently the technology has been performed routinely in all Genea laboratories following IVF, ICSI and PGD treatment cycles. More than 1000 babies have now been born after vitrification at Genea. The vitrification procedure used in this study will be applied to embryos cultured at the Genea Kent Street laboratory for 5 days (blastocyst stage). By vitrifying and NOT TRANSFERRING embryos in “routine” IVF cycle fresh, we wish to see if this will: increase the chance of fetal heart pregnancy and increase the chance of a live born baby
Interventions
Both study groups will undertake a stimulated IVF cycle.
The first( intervention) group will have all embryos cryostored electively for transfer in a later natural menstrual cycle.
The second group will have the best quality embryo transferred to the endometrial cavity fresh and all remaining embryos cryostored.
The protocol for the second group is standard practice today.
Both groups undertake the same drug regime therefore there is no difference in drug intervention
Sponsors
Mark Livingstone
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
Females of infertile couples for whom controlled ovarian stimulation and IVF with or without ICSI is indicated Age at least 20 years but not more than 38 years at the time of screening Regular menstrual cycles with a range of 24-33 days BMI 18-28 AMH 5-20
Exclusion criteria
Previous IVF treatment cycle that resulted in <6 follicles on Day 8 ultrasound More than 2 previous unsuccessful stimulated cycles History of/or current endocrine abnormality such as polycystic ovary syndrome or evidence of ovarian dysfunction Any clinically significant abnormal laboratory value (TSH, PRL, SHBG, Test) Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary Only one ovary Contra-indications for the use of gonadotrophins Alcohol or drug abuse, or history thereof, within the 12 months preceding signing informed consent Smokers
Outcome results
None listed