Patients seeking ART treatments with in vitro fertilization, embryo culture and transfer.
Conditions
Interventions
Oocytes and sperm samples collected from patients who meet the selection criteria will be handled and cultured in either Gx-series medium (study arm), and in G-Plus series medium (control arm). The em
study arm"
month use Gx series medium for gamete handling and pre-implantation embryo culture.
These treatment cycles assigned to "
control arm"
month use G-Plus series medium for gamete handling and pre-implantation embryo culture.
Sponsors
Vitrolife K.K.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients and treatment cycles must meet all of the following conditions: (1) Received informed consent (IC) by physician. The patient age must be between 40 and 45 on the day of IC consultation. (2) Shown to be eligible to the standard IVF treatment procedure in the study clinics by the initial diagnosis results collected before starting IVF treatment.
Exclusion criteria
Exclusion criteria: Patients or treatment cycles applicable to any one of the following conditions: (1) Fertilization is performed with sperms collected through special procedure for male infertility patients: e.g., TESA and TESE. (2) Fertilization is performed with both cIVF and ICSI in a single treatment cycle. (3) Any treatment cycles in which an embryo, either in the study arm or in the control arm, is taken out from the culture for embryo transfer before reaching to blastocysts, such as day 2/3 embryo transfer. (4) Patients who have already been registered in any other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Those rates shall be denominated by per M-II oocytes and per-2PN embryo. (1) Good blastocyst rate (via Gardner's criteria): Grade 3BB or better between day 5 and day 7 (2) Number of Usable Blastocysts per cycles: embryos meeting the criteria of fresh embryo transfer or vitrification (3) Overall blastocyst rate, observed between day 5 and day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) 2PN rate after the insemination, (2) Good embryos on day 3, consist of 6 or more blastomeres with Veeck criteria at 3 or better (3) ET outcomes: embryo implantation defined by HCG+, CPR verified by GS in week 5, OPR verified by fetal heartbeats in week 6 or after (4) AA, AB, BA blastocysts rates | — |
Countries
Japan
Contacts
Public ContactSouichi Ogata
Vitrolife K.K. Scientific support
Outcome results
None listed