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Medium study


Comparing IVF results when using two commercially available culture media -
a multi-center randomized controlled trialObjective


Go to the Medium website.

Objective
To compare two widely used IVF culture media (G5 and HTF) to find out which one leads to the best live birth rate per patient.

Study design

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

Study population
Subfertile couples undergoing their first IVF/ICSI treatment or their first IVF/ICSI treatment after a successful pregnancy.

Intervention
Ovarian hyperstimulation and oocyte retrieval will be performed using standard procedures. In the experimental arm, all oocytes and resulting embryos will be cultured in G5-medium for the duration of one year after randomisation and in the control arm, oocytes and resulting embryos will be cultured in HTF-medium for the duration of one year after randomisation.

Outcome measures
Primary outcome measure will be the percentage of live births after one year of treatment. Secondary outcome measures will be embryo quality, clinical pregnancy rate, miscarriage rate, ongoing pregnancy rate, time to pregnancy, average birth weight and percentage of children with congenital abnormalities.

Power/data analysis
A difference of 10% in ongoing pregnancy rates between the two groups after one year of treatment is considered to be clinically relevant. In the HTF arm of the study an ongoing pregnancy rate of 45% after one year of treatment is expected based on the results from participating centers in the past years. In total, 784 patients are needed to detect a 10% difference in ongoing pregnancy rate after one year of treatment with a power of 80% and an alpha of 5%.


Economic evaluation

Time schedule
The expected duration of the study is three years. The study includes several steps:

  • study preparation (one month)
  • inclusion of patients (twelve months)
  • finish all treatment cycles (twelve months)
  • follow-up to allow patients to reach the primary end-point live birth (nine months)
  • data-analysis and manuscript preparation (two months)

Projectleaders
Drs E Mantikou, AMC
Dr S Mastenbroek, clinical embryologist, AMC
Prof Dr S Repping, clinical embryologist, AMC
Dr A Wetzels, clinical embryologist, UMCN
Dr J van Echten, clinical embryologists, UMCG
Dr D Consten, clinical embryologist, Elisabeth ziekenhuis
Drs E Stappendel, clinical embryologist, Catharina ziekenhuis
Dr J Dumoulin, clinical embryologist, UMCM

Contact
Drs E Mantikou, AMC