Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized,Double-Blind, Placebo-Controlled Trial
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Original Article|Updated:2022-07-20
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Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized,Double-Blind, Placebo-Controlled Trial
Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized,Double-Blind, Placebo-Controlled Trial
Chinese Journal of Integrative Medicine2022年28卷第8期 页码:675-682
Affiliations:
1.College of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan (250355), China
2.The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan (250014), China
3.Reproductive and Genetic Center of Integrated Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan(250011), China
Author bio:
Prof. SUN Zhen-gao, E-mail:sunzhengao77@126.com
Funds:
the National Natural Science Foundation of China(Nos. 81874484 and 81674018)
Yi ZHANG, Yan QIAO, Li LI, 等. Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized,Double-Blind, Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(8):675-682.
Yi ZHANG, Yan QIAO, Li LI, et al. Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized,Double-Blind, Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(8):675-682.
Yi ZHANG, Yan QIAO, Li LI, 等. Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized,Double-Blind, Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(8):675-682. DOI: 10.1007/s11655-022-3515-2.
Yi ZHANG, Yan QIAO, Li LI, et al. Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized,Double-Blind, Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(8):675-682. DOI: 10.1007/s11655-022-3515-2.
Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized,Double-Blind, Placebo-Controlled Trial
摘要
Abstract
Objective:
2
To evalvate efficacy of Qizi Yusi Pills (QYP)
a Chinese medicine compound preparation
on
in vitro
fertilization-embryo transfer (IVF-ET) in women of advanced reproductive age.
Methods:
2
This multicenter
randomized
double-blind
placebo-controlled trial was conducted from June 2018 to October 2019. A total of 124 patients were randomly allocated to either the QYP group or the placebo group using a stratified block randomization design
with 62 patients in each group. All patients completed controlled ovarian stimulation using a standard gonadotropin-releasing hormone agonist (GnRH-a) long protocol. As the QYP group
QYP was administered while the control group received placebo. QYP and placebo were administered for a total of 24 to 30 days from the day of GnRH-a pituitary downregulation to transvaginal oocyte retrieval. Both medications were taken orally at doses of 10 g three times each day. The primary outcome was cumulative pregnancy rate
and the secondary outcomes were periodic medication
follicular status
serum hormone and endometrial receptivity. Follow-up continued until 4 weeks after delivery. Maternal and neonatal complications
such as gestational diabetes
were also observed.
Results:
2
Overall
119 patients completed the study
60 in the QYP group and 59 in the placebo group. Per protocol (PP) analysis revealed that 6-month cumulative pregnancy rate in the QYP group was significantly higher than that in the placebo group [43.33% (26/60) vs. 25.42% (15/59)
P=0.040). Additionally
more oocytes were retrieved from the QYP group than those from the placebo group (8.95±3.12 vs. 7.85±1.91
P
=0.022). Moreover
the endometrial thickness of HCG day in the QYP group was significantly higher than that in the placebo group (11.78±2.27 mm vs. 10.68±2.07 mm
P
=0.012). Maternal and neonatal complications between the two groups were not significantly different (
P
>
0.05). Intention-to-treat analysis was in line with PP results.
Conclusions:
2
QYP can enhance ovarian reserve capacity and ovarian response
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