Overview

Atosiban in Single Blastocyst Transfer in Patients With Previous Pregnancy Failure and Abnormal Uterine Contractions

Status:
NOT_YET_RECRUITING
Trial end date:
2027-09-30
Target enrollment:
Participant gender:
Summary
This study aims to evaluate the efficacy of atosiban in patients with previous pregnancy failure and abnormal uterine contractions during the peri-embryo transfer period in assisted reproductive technology. The main questions it aims to answer are: * Does the use of atosiban in patients with a history of pregnancy loss and abnormal uterine contractions affect the live birth rate in single blastocyst transfer cycles (fresh or frozen-thawed embryo transfer)? * Evaluate the differences in efficacy of atosiban regarding perinatal complications and neonatal outcomes, as well as differences in safety concerning miscarriage rates and ectopic pregnancy rates. Researchers will compare atosiban with placebo (a similar substance containing no active medication) to determine whether atosiban is effective in improving live birth rates from single blastocyst transfer cycles (fresh or frozen-thawed embryo transfer) in patients with a history of pregnancy loss and abnormal uterine contractions. * Participants will receive an intravenous bolus of atoxiban (37.5 mg/5 mL, Tractocile, Ferring Pharma, Geneva, Switzerland) at a rate of 6.75 mg/0.9 mL 30 minutes prior to embryo transfer surgery, followed by a 1-hour intravenous infusion at 18 mg/h. After 1 hour, the atoxiban infusion rate will be reduced to 6 mg/h, with a total dose of 37.5 mg. The atoxiban dosage used in this study is clinically applicable for preterm or infertility women undergoing ET, and its pharmacokinetics are reasonable. In the placebo group, participants will receive an identical-appearing saline infusion over the same time period. * Following infusion completion, all patients in randomised groups will be invited to undergo reassessment of uterine wave patterns via ultrasound, performed by the same examiner. * Subjects undergoing embryo transfer may proceed to the next scheduled visit, planned for 13 to 15 days post-transfer. Should fertilisation fail for any reason or embryo transfer not be performed, the subject shall attend the final visit.
Phase:
NA
Details
Lead Sponsor:
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Treatments:
atosiban