Actively Recruiting
Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions
Led by Northwest Women's and Children's Hospital, Xi'an, Shaanxi · Updated on 2025-12-09
792
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 implantation failure 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 implantation failure and abnormal uterine contractions. * Participants allocated to the Atosiban group will be administered Atosiban (37.5 mg/5 mL, Tractocile®, Ferring Pharma, Geneva, Switzerland) as an intravenous (IV) bolus of 6·75 mg/0.9 mL in 1 minute at 30 minutes prior to the ET procedure, followed by an IV infusion at a rate of 18 mg/h for 1 hour; after 1 hour, the dose of Atosiban will be reduced to 6 mg/h, with a total dose of 37.5 mg. Participants allocated to the placebo group will receive identical-looking saline infusions for the same duration. * One hour post-embryo transfer, all randomized participants will be invited to have a reevaluation of uterine wave patterns via ultrasound, performed by the same examiner. * Women who had a clinical pregnancy will be subsequently contacted by nurses to document pregnancy events and outcomes at 12 and 24 weeks of gestation, completion of pregnancy, with a follow-up approximately 6 weeks post-delivery. Those participants who had a negative pregnancy test will not be followed up any further as part of this trial.
CONDITIONS
Official Title
Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for single blastocyst-stage embryo transfer in a fresh or frozen cycle
- History of one or more implantation failures in previous embryo transfer cycles
- Age between 20 and 40 years inclusive
- Abnormal uterine contractions seen on ultrasound before transfer, such as more than 4 contractions per minute or negative wave patterns
- Participation limited to one transfer cycle per woman
You will not qualify if you...
- Immunologic or endocrine disorders including thyroid dysfunction, antiphospholipid syndrome, hyperprolactinemia, or severe systemic diseases like hypertension or diabetes
- Uterine malformations such as intrauterine adhesions or abnormal uterus shapes
- Untreated hydrosalpinx or endometrial polyps
- Cycles involving in-vitro maturation or oocyte donation
- Previous participation in the Atosiban 1 study
- Current involvement in any other clinical trial
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center for Reproductive Medicine, Northwest Women's and Children's Hospital
Xi'an, Shaanxi, China, 710003
Actively Recruiting
Research Team
H
He Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here