Infertility patients planning to undergo embryo transfer
Conditions
Interventions
On the day of embryo transfer, in the test and control groups, the embryos were thawed and then cultured for 3-7 hours using SAGE 1-Step GM-CSF (test group) or SAGE 1-Step (control group), respectivel
Sponsors
Kobayashi Tatsuya
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Women aged 30 to 39 years at the time of providing informed consent. 2)The age at the time of oocyte retrieval for the embryo to be transferred is between 30 and 39 years. 3)Individuals intending to transfer frozen blastocysts derived from 2PN embryos fertilized via IVF or ICSI. 4)Individuals who have stored frozen blastocysts. 5)Single blastocyst transfer cycle. 6)Patients not participating in any other clinical trials involving interventions related to infertility treatment at the time of providing consent. 7)Patients who have received a comprehensive explanation from the investigator regarding participation in this study and who have provided written informed consent voluntarily, based on a thorough understanding of the study.
Exclusion criteria
Exclusion criteria: 1)Repeated implantation failure, defined as the failure of implantation of three or more good-quality embryos (Gardner's criteria 3BB or more) during attempts to achieve pregnancy. 2)A history of two or more miscarriages within the past year prior to study enrollment. 3)Couples in which either partner has a chromosomal translocation or inversion. 4) Those who currently have an organic uterine abnormality that clearly affects implantation or pregnancy continuation, such as a uterine malformation or submucosal uterine myoma, as determined by at least one of the following tests: transvaginal ultrasound, hysteroscopy, or hysterosalpingography (past medical information is acceptable). 5)Hypersensitivity to GM-CSF. 6)Anticipated difficulty in follow-up, such as relocation within one year. 7)Subjects deemed unsuitable for the safe conduct of the study by the principal investigator or sub-investigator, following consultation with the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth | — |
Secondary
| Measure | Time frame |
|---|---|
| embryo degeneration after recovery culture, implantation (serum human chorionic gonadotropin, >20 IU/ml), clinical pregnancy, fetal heartbeat, Biochemical pregnancy, multiple births, miscarriage, stillbirth, premature birth, neonatal death, induced abortion, birth week, sex ratio of newborns, method of delivery, major congenital anomalies in newborns, neonatal diseases, birth weight, macrosomia, low birth weight, ectopic pregnancy, pregnancy complications (gestational hypertension, preeclampsia, HELLP syndrome, gestational diabetes, abnormal bleeding before delivery, abnormal bleeding during delivery, placenta accreta, abruptio placentae), Safety profile (details of adverse events, incidence rate, grade) | — |
Contacts
Public ContactTatsuya Kobayashi
Fujita Health University
Outcome results
None listed