2.8.1. Efficacy outcomes.
kidney qi-yin deficiency syndrome
SECONDARY, EARLY MISCARRIAGE
The primary outcome is the number of oocytes retrieved per COS cycle.The following secondary outcomes will also be evaluated as secondary outcomes:Symptom rating scores of kidney qi-yin deficiency syndrome after treatment (The symptom rating scales is shown in Table Difference in rating scores of kidney qi-yin deficiency syndrome before and after treatment.Average daily dose of gonadotropin per COS cycle.Total gonadotropin dose and duration of ovarian stimulation per COS cycle.Cycle cancelation rate per COS cycle. Cycle cancelation is defined as a cycle canceled before obtaining at least 1 viable embryo for any reason.Good quality embryos rate per embryo. A good quality embryo is defined as an embryo that is graded as 6-cell grade 2 (6CII) or better or blastocyst.Embryo implantation rate per embryo, defined as the number of gestation sacs detected divided by the number of embryos transferred.Clinical pregnancy rate per patient, defined as the number of women with identified clinical pregnancies divided by the number of patients randomized to a specific group. Clinical pregnancy is confirmed when 1 or more gestational sacs are detected on transvaginal ultrasound assessment.Early miscarriage rate per patient, defined as the percentage of participants with loss of a diagnosed clinical pregnancy before 12 weeks gestation to the total patients randomized.CLBR per patient, defined as the proportion of deliveries with at least 1 live birth per started cycle or oocyte aspiration, including all fresh and/or frozen embryo transfers until 1 delivery with a live birth or until all embryos were used (within 1 year after randomization).Symptom rating scales of kidney qi-yin deficiency syndrome.