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.

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.

Association of TNF-α gene T-1031C polymorphism with endometriosis: A meta-analysis.

The single nucleotide polymorphism T-1031C has shown to have an important role in the regulation and transcription efficiency of TNF-α gene. Yet, the relationship between TNF-α T-1031C gene polymorphism and the development of endometriosis (EM) still remains unclear. The aim of this meta-analysis was to summarize the effects of TNF-α T-1031C gene polymorphism and clarify their possible association with EM. A comprehensive literature search was performed using PubMed, EMBASE, Web of Science, and the Cochrane Central Register of Controlled Trials (up to August 10, 2019). A fixed- or random-effects model was employed according to the heterogeneity among studies. The log odds ratios and 95% confidence intervals (CIs) were estimated in the models of allele comparison (T vs C), homozygote comparison (TT vs CC) and (TC vs CC), dominant (TT vs TC + CC), hyperdominant (TT + CC vs TC), and recessive (TT + TC vs CC) to estimate the strength of the associations. A total of 7 case-control studies were included in this meta-analysis. Overall, significant associations between TNF-α T-1031C and EM were identified from (T vs C: log OR [95% CI] = 0.31 [-0.09, 0.71]; TT + CC vs TC: 0.27 [0.04, 0.50]; TC + CC vs TT: -0.83 [-1.19, -0.47]). On the other hand, no significant correlation was found in other gene models (TT vs TC: log OR [95% CI] = 0.89 [0.64, 1.13]; TT vs CC: 0.3 [-0.74, 1.36]; TT + TC vs CC: 0.17 [-0.81, 1.15]). In subgroup analyses by ethnicity or HWE P-value, there was a statistically significant association between TNF-α T-1031C polymorphisms and EM in the dominant model (TT vs TC + CC: log OR [95%] = -0.84 [-1.60, -0.09]) for the European population, and in hyperdominant model (TT + CC vs TC: log OR [95%] = 0.24 [0.001, 0.49]) for Asian population. To sum up, this meta-analysis showed that TNF-α T-1031C polymorphism was associated with EM susceptibility and has a protective effect in Asian and European populations.

[Differences on ethical consciousness issues between the Chinese Journal of Epidemiology and the American Journal of Epidemiology].

To compare the differences on current ethical issues in the areas of epidemiological practice between China and America, to identify the major ethical problems existing in the epidemiological studies in China. Through searching and reviewing papers published on Chinese Journal of Epidemiology and American Journal of Epidemiology from Jan. 2006 to Dec. 2010, we made a comparison on ethical issues involved in the original studies that focusing on human beings. In total, 749 Chinese articles and 1221 American articles were recruited, with the following findings: (1) The proportion with announcements of "Informed consent by the subjects" was 29.24% in Chinese literature and 38.08% in the Americans (χ² = 16.02, P < 0.001). The proportion with "having had approvals from the ethic committees" was 29.24% in Chinese, while 38.08% in American (χ² = 604.40, P < 0.0001). (2) Both in China and America, there had been an increase of ethical issues in the last 5 years. (3) Articles derived from trial studies had better involvement on ethics than those from observational studies. (4) The level on ethical issues in the American Research Institutes exceeded those in China (5) American studies also had showed better ideas on Ethic issues on biological specimens collection and privacy protection, than those in Chinese studies. Among the studies on Chinese Journal of Epidemiology, the proportion of 'informed consent' was higher than in ethical review, but both ethical review and awareness on 'informed consent' had left far behind than the American Journal of Epidemiology. This could be seen at the institution level of the writers, during specimen collection and privacy protection, as well as at the overall level. The results reminded us that the Departments of Technology Management should spend more efforts on the improvement of public education regarding ethics for researchers and to update the process of edition for Journals as well as to reinforce the rules of ethics in epidemiological research.