Clinical study of Time-Lapse incubator

UMIN ID: UMIN000055611

Registered date:01/11/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Patients seeking ART treatments with in vitro fertilization, embryo culture and transfer.
• Date of first enrollment: 2022/08/20
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Fertilized oocytes in the treatment cycles which meet the selection criteria after insemination will be randomly split into the test arm and the control arm. Embryos in the test arm are cultured in the test equipment "EmbryoScope+ time lapse incubator". Embryos are cultured continuously up to blastocysts stage, usually for 5-7 days from the insemination.
Embryos in the control arm are cultured in the conventional incubator normally used in the test sites. Embryos are cultured continuously up to blastocysts stage, usually for 5-7 days from the insemination.

Outcome(s)

• Primary Outcome: Those rates shall be denominated by per M-II oocytes and per-2PN embryo. (1) Overall blastocyst rate, observed between day 5 and day 7 (2) Good blastocyst rate: Grade 3BB or better between day 5 and day 7 (3) Number of Usable Blastocysts per cycles: embryos meeting the criteria of fresh transfer and freezing of the study clinics
• Secondary Outcome: (1) 2PN rate after the insemination, embryo morphology grades on day 3 (2) Grade AA/AB/BA blastocysts (top-rated blastocysts) (3) ET outcomes, including HCG+/-, CPR verified by GS in week 7, OPR verified by fetal heartbeats in week 13

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 50years-old
• Gender: Male and Female
• Exclude 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) Oocytes which require in vitro maturation (IVM) shall be excluded from the sample pool. However, it shall include those treatment cycles found with six or more of normally fertilized oocytes after excluding IVM oocytes. (5) Patients already been registered in any other clinical studies.

Related Information

• Primary Sponsor: Vitrolife K.K.
• Source(s) of Monetary Support: (N/A)