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

The objective of this study is to investigate the effect of GSATP of hormone therapy (HT) FET cycles on pregnancy rate.MethodsA 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-ul trasound 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.DiscussionDifferences 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 registrationChiCTR1900026737. Registered October 20, 2019.
Source: Trials - Category: Research Source Type: clinical trials