Primary or secondary infertility
Conditions
Interventions
IVF group:In Vitro Fertilization
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.For male patients: A definitive diagnosis of isolated non-specific teratozoospermia, meeting the diagnostic criteria specified in the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition): normal sperm morphology rate 4%, with normal semen concentration and motility (total sperm count =39 million per ejaculate, progressive motility (PR) =32%). 2.For female subjects: i) First or second ovarian stimulation cycle; ii) Receiving controlled ovarian hyperstimulation (COH) treatment with a gonadotropin-releasing hormone agonist (GnRH-a) protocol or gonadotropin-releasing hormone antagonist (GnRH-ant) protocol. 3.Both partners voluntarily enrol in this research and provided signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Couples undergoing preimplantation genetic testing for embryos (PGT-A/PGT-M/PGT-SR). 2.Couples receiving donor sperm, donor oocytes, frozen sperm, or sperm retrieved via testicular surgery. 3.Couples with a fertilization rate =25% in the previous controlled ovarian stimulation cycle. 4.Females with a history of recurrent spontaneous abortion: three or more spontaneous miscarriages (including biochemical pregnancy). 5.Either partner with abnormal chromosomal karyotype (excluding chromosomal polymorphisms), or suffering from diseases unsuitable for childbearing as stipulated in the Maternal and Infant Health Care Law. 6.Females with contraindications to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), including: poorly controlled type 1/type 2 diabetes, unexplained liver or kidney dysfunction, severe anemia, history of deep vein thrombosis or pulmonary embolism, history of cerebrovascular accident, poorly controlled hypertension, symptomatic heart disease, history of gynecological malignant tumors (cervical cancer, endometrial cancer, breast cancer), unexplained vaginal bleeding, severe psychiatric disorders, acute genitourinary infections/sexually transmitted diseases, drug abuse, and exposure to teratogenic doses of radiation, toxicants or medications within their effective exposure period. 7.Males with contraindications to assisted reproductive technology (ART): severe psychiatric disorders, acute genitourinary infections or sexually transmitted diseases, drug abuse, and exposure to teratogenic doses of radiation, toxicants or medications within their effective exposure period. 8.Couples enrolled in other randomized controlled trials (RCTs). 9.Vulnerable populations, including individuals with psychiatric illnesses, cognitive impairment, critically ill patients, minors, pregnant women, illiterate persons, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Summarize all outcomes of fresh and frozen-thawed embryo transfers;Second-trimester miscarriage; fetal structural malformations;Number of high-quality embryos; number of transplantable embryos;Number of usable blastocysts;Ectopic pregnancy; multiple pregnancy;Peripheral blood beta-human chorionic gonadotropin;Inquire about the plan for frozen-thawed embryo transfer;Clinical pregnancy; number of implantations;Early miscarriage;Neonatal follow-up; | — |
Countries
China
Contacts
Public ContactSongying Zhang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed