Infertility
Conditions
Interventions
Test Group:vitrification medium, warming medium
Control group:Vitrification Media Kit, Thawing Media Kit
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
20 Years to 38 Years
Inclusion criteria
Inclusion criteria: 1. Both spouses were able to fully understand the purpose of the screening, demonstrate adequate compliance with the study protocol, and sign informed consent forms; 2. Female participants were aged 20 to 38 years at the day of signing the informed consent; 3. Body mass index (BMI) of female participants' BMI 18 kg/m2 to 27kg/m2; 4. Indication for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI); 5. In the first half of the year after enrollment, serum follicle-stimulating hormone (FSH) levels within the range of 1-10 IU/L on day 2 ~ 4 of menstruation; in the first half of the year after enrollment, levels of luteinizing hormone (LH), estradiol (E2), prolactin (PRL), progesterone (P) and testosterone (T) on day 2-4 of menstruation were within normal range in clinical laboratory, or mild abnormalities that researchers believe have no practical clinical significance; 6. In the first half of the year after enrollment, serum human immunodeficiency virus (HIV) antibody, treponema pallidum gelatin particle agglutination test (TPPA) and hepatitis C virus antibody (HCV-Ab) tests were negative; 7. Number of high-quality blastocysts >=2 at D5 and/or D6 according to Gardner blastocyst criteria (evaluated on the day of enrollment); 8. Patients who do not undergo embryo transfer during the fresh embryo transfer; 9. Both spouses in this trial were willing to undergo single warmed-blastocyst transfer; 10. Both spouses use autologous germ cells for assisted reproduction.
Exclusion criteria
Exclusion criteria: 1. Participants who have ovarian cysts >30 mm in diameter, submucous myoma or intramural myoma >30 mm in diameter, pituitary tumors and malignant tumors of various tissues and organs; or as judged by the researcher, patients with clinically significant uterine abnormalities (endometrial polyps, intrauterine adhesions, uterine anomalies, ASRM ? to IV endometriosis), accessories (hydrosalpinx) abnormalities; 2. Previous IVF-ET/ICSI oocyte retrieval for >=3 cycles without clinical pregnancy; 3. Unexplained abnormal vaginal bleeding; 4. Known to coincide with active pelvic inflammatory disease; 5. Known genital malformations unsuitable for pregnancy; 6. Abnormal clinically significant cervical cytology findings within 1 year prior to enrollment; 7. Patients with severe hepatic and renal impairment; 8. Severe heart disease, hypertension, unstable angina pectoris, cardiac insufficiency grade III or higher, acute myocardial infarction and/or old myocardial infarction; 9. Known previous or current thrombophlebitis or thromboembolism including venous thrombosis (e.g., deep vein thrombosis and portal vein thrombosis, etc.) and active or recent arterial thrombosis (e.g., stroke and myocardial infarction, etc.) within 1 year prior to screening; 10. Any known endocrine or metabolic abnormality (e.g., hypophysis, adrenal gland, pancreas, hepatic, or renal) that would affect the participant's involvement in this trial, except for controllable functional thyroid disease; 11. Any known clinically significant systemic disease (e.g., insulin-dependent diabetes or tuberculosis); 12. Known history of chemotherapy or radiotherapy; 13. Known history of adverse pregnancy and childbirth in women; 14. Chromosome karyotype abnormality of either spouse; 15. Either of the spouses suffers from hereditary diseases that are not suitable for reproduction as stipulated in Maternal and Child Health Law; 16. Either spouse has a history of drug use; 17. Either spouse currently consumes more than 14 units of alcohol per week (within 30 days before screening); 18. Either spouse currently or in the past has the habit of smoking more than 10 cigarettes a day (within 90 days before screening); 19. Either spouse is exposed to radiation, poisons, and drugs causing deformity; 20. Either spouse has given birth to a fetus with genetic defects or chromosomal abnormalities or a known PGD, PGS screening; 21. Female participants are pregnant, lactating, or have pregnancy contraindications; 22. Participated in other drug or medical device clinical trials within 3 months prior to the enrollment; 23. According to the judgment of the researcher, there are any physical conditions that may affect the device evaluation/combined surgery/medication administration/abnormal laboratory examinations of clinical significance; 24. Known refusal or inability to comply with protocol requirements for any reason (including planned clinical visits and examinations).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blastocyst survival rat; | — |
Secondary
| Measure | Time frame |
|---|---|
| ß-HCG positive rate;Implantation rate;Clinical pregnancy rate;Ongoing pregnancy rate;Abortion rate;Incidence of fetal malformation;Live birth rate; | — |
Countries
China
Contacts
Public ContactYingpu Sun
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed