Infertility
Conditions
Interventions
Experimental Group (Single - step Culture Medium Group):Use a single culture medium throughout the process without replacement
Control Group (Sequential Culture Medium Group):Use cleavage - stage culture medium from D0 - D3, and replace it with blastocyst - stage culture medium after D3 until the end of culture (D5 - D6)
Sponsors
Shanghai First Maternity and Infant Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Infertile women with normal ovarian function, aged 20-45 years, who plan to receive assisted reproductive technology for pregnancy assistance in our hospital from October 2025 to September 2027.
Exclusion criteria
Exclusion criteria: (1) Uterine malformations without surgical correction (such as a uterine septum > 1.5 cm, severe intrauterine adhesions) or severe endometriosis (ASRM stage ?/? without completion of drug treatment for = 3 months); (2) Recurrent miscarriage (= 2 spontaneous abortions before 20 weeks of pregnancy) with unclear causes or without treatment; (3) Severe oligozoospermia or asthenozoospermia requiring surgical sperm retrieval (sperm concentration from testicular biopsy < 1×106/mL) or severe teratozoospermia (proportion of normal - shaped sperm < 1%); (4) Chromosomal abnormalities in either spouse; (5) Uncontrolled endocrine diseases, such as severe polycystic ovary syndrome with hyperandrogenemia/insulin resistance, diabetes, abnormal thyroid function, etc.; (6) Egg donation cycles/sperm donation cycles/HIV preventive treatment cycles (for couples with inconsistent serostatus)/fertility preservation cycles (such as egg freezing/embryo freezing for cancer patients)/preimplantation genetic testing (PGT) cycles; (7) No mature oocytes (MII stage) obtained in this treatment cycle.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical pregnancy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fertilization rate;Cleavage rate;D2/D3 high - quality embryo rate;D2/D3 usable embryo rate;D5/D6 high - quality blastocyst rat;Blastocyst formation rate;Usable blastocyst rate;Biochemical pregnancy rate;Biochemical pregnancy loss rate;Embryo implantation rate;Ongoing pregnancy rate;Miscarriage rate;Live birth rate;Twin pregnancy rate; neonatal birth weight;Ectopic pregnancy;Gestational diabetes mellitus;Gestational hypertension;Placental abruption;Placenta previa;Premature rupture of membranes;Preterm birth;Low birth weight;Macrosomia;Congenital malformations ; | — |
Countries
China
Contacts
Public ContactYi Guo
Shanghai First Maternity and Infant Hospital
Outcome results
None listed