Human Clinical Trial
— AntioxidantsOfficial title:
Comparison of G-Series Media System With Antioxidants Versus Standard G-Series Media System
Verified date | November 2018 |
Source | Vitrolife |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Upon collection, human oocytes are fertilized and culture up to the blastocyst stage,
followed by transfer and / or cryopreservation. Culture media systems have been developed
that support each step of this process. Although these culture media systems try to mimic the
natural environment, several components of the in-vivo situation are not present in today´s
media. One such component is anti-oxidants that may protect embryos against damage by
reactive oxygen species.
This investigation aims to compare blastocyst development using 2 different types of culture
media systems, one of which contains antioxidants. Patients having at least eight oocytes and
meeting other inclusion criteria can be included in this investigation.
It is a prospective randomized multicenter study randomly dividing oocytes into two groups
and assessing parameters of embryo development from fertilization up to blastocyst formation
until day six. Embryos with acceptable developmental characteristics can be transferred into
the uterus or cryopreserved for later use.
The investigation is designed as a superiority study comparing utilization rate of
blastocysts per normally fertilized oocyte using both media systems. In patients receiving
embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound
after 12 weeks gestation is the final endpoint of the investigation.
Status | Completed |
Enrollment | 128 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Minimum eight cumulus-oocyte-complexes. - Couples with female, male or unexplained infertility intending to undergo IVF - The couple should have received verbal and written information/consent about the study. - Blastocyst culture and embryo transfer is decided. - If the couple fulfills the criteria above their consent to participate must be given and documented in the couple's medical journal. Exclusion Criteria: - Previous participation in the study - PGD/PGS - Surgically retrieved sperm cells (TESA / TESE) - If split IVF is needed - Less than eight cumulus-oocyte-complexes - More than thirty cumulus-oocyte-complexes |
Country | Name | City | State |
---|---|---|---|
Japan | Kuramoto Women´s Clinic | Fukuoka | |
Japan | Kiba Park Clinic | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Vitrolife |
Japan,
Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of good quality blastocyst (GQB) per fertilized oocyte on day 5 | 7 months | ||
Secondary | Embryo development on day 3, 5 & 6 | 7 months | ||
Secondary | Embryo quality on day 3, 5 & 6 | 7 months | ||
Secondary | Total blastocyst rate | 7 months | ||
Secondary | Blastocyst utilization rate per fertilized oocyte | 7 months | ||
Secondary | Biochemical pregnancy rate | 8 months | ||
Secondary | Clinical pregnancy rate | 9 months | ||
Secondary | Implantation rate | 8 months |
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