Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions

Sponsor
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Study ID
NCT07185230
Status
Recruiting
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Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Atosiban — DRUG
    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.
  • Placebo Control — DRUG
    Participants allocated to the placebo group will receive identical-looking saline infusions for the same duration.

Study Details

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.

Key Dates

First listed
Sep 22, 2025
Start date
Dec 6, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
792 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atosiban group
    Participants allocated to the Atosiban group will be administered Atosiban
  • Placebo Comparator: Placebo group
    Participants allocated to the placebo group will receive saline infusions.

Primary Outcome Measure

Live birth [ Time Frame: After 24 weeks of gestation ]

Central Contacts

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