The purpose of this study is to investigate whether oral Gushen Antai pills supplementation for luteal phase support will improve ongoing pregnancy rate in women with normal ovarian reserve in fresh embryo transfer cycles.
Patients with normal ovarian function reserve (5 ≤ AFC ≤ 15, 1.2 ng/ml ≤ AMH ≤ 3.5 ng/ml).
Patients with regular menstrual cycle (21-35 days) and normal ovulation.
Initial IVF / ICSI treatment.
At least one embryo or blastocyst available for transfer.
Age ≥ 43 years old.
Body mass index (BMI) ≥ 28 Kg/m2.
"Freeze-all" strategy.
Those using the natural cycle or mild stimulation for IVF/ICSI treatment.
Parallel
Gushen Antai Pill
DrugThe Gushen Antai Pill (GSATP, Z20030144) is composed of 10 herbs including radix-polygoni multiflori, radix rehmanniae praeparata, cistanche salsa, radix dipsaci, uncaria, semen cuscutae, rhizoma atractylodis macrocephalae, radix scutellariae, radix paeoniae lactiflorae. Its production follows GMP standards and takes the form of water honey pills, each bag of 6g.
Placebo pill
DrugThe placebo pill is produced by Beijing boran Pharmaceutical Co., Ltd. It can simulate the appearance, color and smell of GSATP formula, but it has no clinical effect because it has no active ingredients.
Ongoing pregnancy rate
A fetal heartbeat detected by transvaginal ultrasonography over 12 gestational weeks. \[Detected via ultrasound\]
Positive pregnancy rate
Serum β-hCG level ≥ 10mIU/mL, 14 days after embryo transfer. \[Detected via ELISA\]
Embryo implantation rate
The number of intrauterine gestational sacs observed divided by the number of embryos transferred. \[Detected via ultrasound\]
Clinical pregnancy rate
An intrauterine gestational sac with fetal heartbeat detected by transvaginal ultrasonography. \[Detected via ultrasound\]
Ectopic pregnancy rate
A pregnancy in which implantation takes place outside the uterine cavity. \[Detected via ultrasound\]
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