Examination of the pregnancy-promoting effect of GM-CSF-containing medium in frozen-thawed blastocyst transfer cycle

JRCT ID: jRCT1040240159

Registered date:06/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Infertility patients planning to undergo embryo transfer
• Date of first enrollment: 06/01/2025
• Target sample size: 750
• Study type: Interventional

Intervention(s)

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), respectively. The blastocysts were transferred into the uterus with a small amount of culture medium.
If hyaluronic acid-containing culture medium is used for embryo transfer, the blastocyst is thawed and then cultured for 3-7 hours using SAGE 1-Step GM-CSF (test group) or SAGE 1-Step (control group), respectively as a recovery culture.
Then, the blastocyst was transferred to a hyaluronic acid-containing medium, and the blastocyst is then transferred into the uterus together with a small amount of culture medium.

Outcome(s)

• Primary Outcome: Live birth
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 40age old
• Gender: Female

Include 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.

Exclude 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)Evidence of current organic abnormalities of the uterus, such as uterine malformations or submucosal fibroids, identified through at least one of the following examinations: transvaginal ultrasonography, hysteroscopy, or hysterosalpingogram (past medical records are 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.

Related Information

• Primary Sponsor: Kobayashi Tatsuya
• Source(s) of Monetary Support: Fujita Health University,Takeda Science Foundation