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Comparing IVF results when using two commercially available culture media (part 2) - a multi-centre randomized controlled trial

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To compare two internationally widely used IVF culture media, the sequential culture medium G5 (G1.5 for culture on day 1-3 and G2.5 for day 4-6) from Vitrolife (Sweden) and a single step Continuous Single Culture Medium (CSCM) from Irvine (Ireland), to find out which one leads to the best live birth rate per patient after one IVF/ICSI cycle and to investigate their effect on perinatal outcome of the resulting children. 

Study design
A multi-center, randomized, double-blinded comparison of G5 and CSCM for human preimplantation embryo culture.

Study population
Subfertile couples undergoing their first IVF/ICSI treatment ever or after a successful pregnancy will be included. Patients undergoing a PGD cycle, patients for which IVF is used to prevent the transmission of HIV, patients undergoing a modified natural cycle, patients requiring TESE or PESA and patients requiring gestational surrogacy will be excluded. A 1980 patients will be included in the study.

The IVF treatment (clinical and laboratory procedures) will be performed as usual in each clinic. Randomization will decide in which commercially available culture medium (either G5 or CSCM) to culture all oocytes and resulting embryos of each patient. Only the first cycle, including the transfer of embryos in a fresh cycle and the transfer of frozen embryos (if any) from that cycle within one year after randomization, is included in this study. In second or subsequent cycles the culture medium of choice in each IVF laboratory will be used. 

Outcome measures
Primary outcome measure will be the percentage of live births after one cycle in each group. Secondary outcome measures will be embryo development, implantation rate, clinical pregnancy rate, miscarriage rate, ongoing pregnancy rate, multiple pregnancy rate, morphometric parameters of foetal development at 8, 12 and 20 weeks of pregnancy, mean values of maternal serum markers during first trimester screening, mean birth weight, mean gestational age at birth and percentage of children with congenital abnormalities.

Power/data analysis
The primary outcome measure is live birth rate after one cycle including culture and transfer of fresh and frozen embryos. A difference in cumulative live birth rate of 6% is considered clinically relevant. In the G5 arm of the study a live birth rate of 28% after one cycle (including transfer of cryopreserved embryos) is expected based on the results from participating centers in the previous years (www.nvog.nl). In total, 1980 patients are needed to detect a 6% difference (two-sided) in live birth rate with a power of 80% and an alpha of 5%. 

Economic evaluation
Not applicable.

Time schedule
Couples presenting for their first IVF/ICSI treatment ever, or after a successful pregnancy, in one of the seven collaborating centres will be asked for participation in this study. The treatment protocol and study interventions allow most new patients presenting in the participating centres to be eligible for inclusion. Given the fact that approximately 3000 new patients are treated in the participating centres each year, and with an expected inclusion rate of 40%, it will take 20 months to complete the inclusion. This is considered realistic as in our previous MEDIUM1 study an inclusion rate of 60% was obtained

MUMC+: Dr. J. Dumoulin
AMC: Dr. S. Mastenbroek

Health Technology Assessment 
Not applicable

Not applicable


Contact (researcher)
Dr. A.P.A. van Montfoort Researcher MUMC+ aafke.van.montfoort@mumc.nl 
Drs. H. Zandstra PhD-student/IVF-arts MUMC+. heleen.zandstra@mumc.nl