This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI). Qualified 1422 patients are randomized into either of two groups: group A will undergo conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic sperm injection (ICSI) (711 cases). All participants will receive the same protocol for ovarian stimulation and standardized luteal phase support. The target population will be patients with non-male factor infertility aged ≥38years with FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded. The randomization will take place before controlled ovarian stimulation by a computer randomization system. The accumulated live birth rate , pregnancy complications will be followed up by checking medical records and telephone calls.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,422
A technique that involves microinjection of spermatozoa into mature oocytes.
A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.
International Peace Maternity & Child Health Hospital
Shanghai, Shanghai Municipality, China
accumulated live birth rate
This will be based on the outcome of either the ICSI or the outcome of the IVF as will all other secondary outcomes
Time frame: 42 weeks
Fertilization rate
Fertilization rate was defined as the percentage of fetal heart beat among total retrieved oocytes
Time frame: 1 day after fertilization
Embryo quality
Embryo quality was evaluated by microscopy.
Time frame: 3day after fertilization
clinical pregnancy rate
Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
Time frame: 35 days after embryo transfer
implantation rate
Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
Time frame: 11-12 weeks after embryo transfer
biochemical pregnancy rate
Biochemical pregnancy was defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.
Time frame: 2 weeks after embryo transfer
pregnancy loss rate
Pregnancy loss is defined as any reason that resulted in failure of an embryo to develop, embryonic or fetal death, or spontaneous expulsion of a pregnancy.
Time frame: 28 gestational weeks in maximum
ectopic pregnancy rate
Ectopic pregnancy is defined as an embryo implanted outside the uterine.
Time frame: 12 gestational weeks in maximum
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