scholarly journals Study protocol: a multi-center, double-blind, randomized, 6-month, placebo-controlled trial to investigate the effect of supplementing hormone therapy FET cycles with Gushen’antai pills on the outcomes of in vitro fertilization

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ying-jie Ma ◽  
Xian-ling Cao ◽  
Ting Ma ◽  
Jing-yan Song ◽  
Ling-yu Yu ◽  
...  

Abstract Background Infertility is a widespread global challenge. Currently, the most effective treatment strategy for infertility is in vitro fertilization (IVF), which is an assisted reproductive technique (ART). The use of IVF for assisted pregnancy dates back to the last 41 years when the first IVF baby was born. During IVF, many oocytes are obtained in an IVF cycle, and more than one embryo is formed. Subsequently, frozen-thawed embryo transfer (FET) is increasingly being used in IVF cycles for women in whom a fresh embryo transfer fails to result in a pregnancy, or in those who return for a second baby. However, the pregnancy success rates following FET treatment cycles are reportedly lower than in fresh embryo transfers. Therefore, recent related studies are increasing determining mechanisms of improving the sustained pregnancy rate of FET and reducing the rate of early abortion. The Gushen’antai pill (GSATP), which contains a mixture of 10 herbs, has been widely used in traditional Chinese medicine (TCM) as a pharmacological option to prevent miscarriage. However, randomized controlled trials (RCT) have never been conducted to provide high-level clinical evidence on the clinical efficacy of GSATP. The objective of this study is to investigate the effect of GSATP of hormone therapy (HT) FET cycles on pregnancy rate. Methods A total of 300 subjects aged between 18 and 40 years which prepared for HT cycle FET will be enrolled in the study. The patients were from five different hospitals, with 60 patients from each hospital. Patients were randomly divided into two groups, and medication was started on the day of endometrial transformation. After FET 28 days, B-ultrasound was done to determine whether to continue the medication. Baseline assessments were carried out before the trial and outcomes were collected 4, 6, 8, 10, and 12 weeks of each gestational cycle. Discussion Differences in ongoing pregnancy rate, clinical pregnancy rate, implantation rate, and threatened abortion rate between the two groups will be statistically analyzed. We can finally have an objective evaluation of the efficacy of the traditional Chinese medicine Gushen’antai pills. Trial registration ChiCTR1900026737. Registered October 20, 2019.

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Alessio Paffoni ◽  
Marco Reschini ◽  
Valerio Pisaturo ◽  
Cristina Guarneri ◽  
Simone Palini ◽  
...  

Abstract Background Total fertilization failure represents a particularly frustrating condition for couples undergoing in vitro fertilization. With the aim of reducing the occurrence of total fertilization failure, intracytoplasmic sperm injection (ICSI) has become the first choice over conventional in vitro fertilization (IVF) procedures although evidence of improved results is still debated and its use in couples without male factor infertility is not recommended. Among the strategies potentially useful to promote the use of conventional IVF, we herein call attention to the late rescue ICSI, which consists in performing ICSI after 18–24 h from conventional insemination on oocytes that show no signs of fertilization. This treatment has however been reported to be associated with a low success rate until recent observations that embryos derived from late rescue ICSI may be transferred after cryopreservation in a frozen-thawed cycle with improved results. The aim of the present study was to assess whether frozen embryos deriving from rescue ICSI performed about 24 h after conventional IVF may represent a valuable option for couples experiencing fertilization failure. Methods A systematic review on the efficacy of late rescue ICSI was performed consulting PUBMED and EMBASE. Results Including twenty-two original studies, we showed that clinical pregnancy rate per embryo transfer and implantation rate obtainable with fresh embryo transfers after rescue ICSI are not satisfactory being equal to 10 and 5%, respectively. The transfer of cryopreserved rescue ICSI embryos seems to offer a substantial improvement of success rates, with pregnancy rate per embryo transfer and implantation rate equal to 36 and 18%, respectively. Coupling rescue ICSI with frozen embryo transfer may ameliorate the clinical pregnancy rate for embryo transfer with an Odds Ratio = 4.7 (95% CI:2.6–8.6). Conclusion Results of the present review support the idea that r-ICSI coupled with frozen embryo transfer may overcome most of the technical and biological issues associated with fresh transfer after late r-ICSI, thus possibly representing an efficient procedure for couples experiencing fertilization failure following conventional IVF cycles. Trial registration Prospero registration ID: CRD42021239026.


2015 ◽  
Vol 30 (6) ◽  
pp. 602-612 ◽  
Author(s):  
Lee E. Hullender Rubin ◽  
Michael S. Opsahl ◽  
Klaus E. Wiemer ◽  
Scott D. Mist ◽  
Aaron B. Caughey

2021 ◽  
Author(s):  
Chun-Xiao Wei ◽  
liang zhang ◽  
Cong-Hui Pang ◽  
Ying-Hua qi ◽  
Jian-Wei Zhang

Abstract BackgroundThe outcome of in vitro fertilization-embryo transfer is often determined according to follicles and estradiol levels following gonadotropin stimulation. However, there is no accurate indicator to predict pregnancy outcome, and it has not been determined how to choose subsequent drugs and dosage based on the ovarian response. This study aimed to make timely adjustments to follow-up medication to improve clinical outcomes based on the potential value of estradiol growth rate. MethodsSerum estradiol levels were measured on the day of gonadotrophin treatment (Gn0), four days later (Gn4), seven days later (Gn7), and on the trigger day (HCG). The ratio was used to determine the increase in estradiol levels. According to the ratio of estradiol increase, the patients were divided into four groups: group A1 (Gn4/Gn0≤6.44), group A2 (6.44˂Gn4/Gn0≤10.62), group A3 (10.62˂Gn4/Gn0 ≤21.33), and group A4 (Gn4/Gn0>21.33); group B1 (Gn7/Gn4≤2.39), group B2 (2.39˂Gn7/Gn4≤3.03), group B3 (3.03˂Gn7/Gn4≤3.84), and group B4 (Gn7/Gn4>3.84). We analyzed and compared the relationship between data in each group and pregnancy outcome. ResultsIn the statistical analysis, the estradiol levels of Gn4 (P = 0.029, P = 0.042), Gn7 (P< 0.001, P = 0.001), and HCG (P< 0.001, P = 0.002), as well as the ratios of Gn4/Gn0 (P = 0.004, P = 0.006), Gn7/Gn4 (P = 0.001, P = 0.002), and HCG/Gn0 (P< 0.001, P< 0.001) both had clinical guiding significance, and the lower one significantly reduced the pregnancy rate. The outcomes were positively linked to groups A (P = 0.040, P = 0.041) and B (P = 0.015, P = 0.017). The logistical regression analysis revealed that group A1 (OR = 0.440 [0.223–0.865]; P = 0.017, OR = 0.368 [0.169–0.804]; P = 0.012) and B1 (OR = 0.261 [0.126–0.541]; P< 0.001, OR = 0.299 [0.142–0.629]; P = 0.001) had opposite influence on outcomes. ConclusionMaintaining a serum estradiol increase ratio at least above 2.39 on Gn7/Gn4 may result in a higher pregnancy rate. When estradiol growth is not ideal, gonadotrophin dosage should be adjusted appropriately to ensure the desired outcome.


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