Actively Recruiting
Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions Undergoing Single Blastocyst-Stage Embryo Transfer: A Randomised Triple-Blind, Placebo-Controlled Trial
Led by Northwest Women's and Children's Hospital, Xi'an, Shaanxi · Updated on 2025-12-09
792
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of atosiban in women with infertility who have experienced previous pregnancy failures and abnormal uterine contractions during the time around embryo transfer in assisted reproductive technology. The study aims to see if atosiban improves live birth rates in single blastocyst transfer cycles, whether fresh or frozen-thawed. It also examines differences in perinatal complications, neonatal outcomes, miscarriage rates, and ectopic pregnancy rates. Participants are randomly assigned to receive either atosiban or a placebo. Those in the atosiban group receive an intravenous bolus 30 minutes before embryo transfer, followed by an infusion with a decreasing dose over about two hours. The placebo group receives saline infusions that look identical and last the same length of time. One hour after embryo transfer, uterine contractions are reevaluated by ultrasound. Women with clinical pregnancies are followed up by nurses at 12 and 24 weeks of pregnancy and again about six weeks after delivery to record pregnancy events and outcomes. Those without pregnancy are not followed further. The main outcome measured is live birth after 24 weeks of gestation, with additional assessments including biochemical and clinical pregnancy, miscarriage, stillbirth, ectopic pregnancy, multiple pregnancy, and various newborn health indicators.
CONDITIONS
Brief Title
Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women scheduled for single blastocyst-stage embryo transfer, 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 peristalsis on ultrasound before transfer, defined as either high-frequency contractions (>4 per minute) or a negative wave pattern
- Only one transfer cycle participation allowed per woman
You will not qualify if you...
- Immunologic or endocrine disorders including thyroid dysfunction, antiphospholipid syndrome, hyperprolactinemia, or severe systemic diseases such as hypertension or diabetes
- Uterine malformations like intrauterine adhesions or septate uterus
- Untreated hydrosalpinx or endometrial polyps
- Use of in-vitro maturation or oocyte donation cycles
- Previous participation in the Atosiban 1 study
- Current participation in any other clinical trial
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 hours on the day of embryo transfer
Participants receive Atosiban or placebo via intravenous infusion around the time of embryo transfer.
1 visit (in-person) for embryo transfer and infusion
Duration - Up to approximately 1 year after birth
Participants are monitored for pregnancy outcomes and birth-related measures up to one year after birth.
Multiple visits depending on pregnancy milestones and birth outcomes
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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