Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions

NCT ID: NCT07185230

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 792 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-06
• Study Completion Date: 2027-09-30

Brief 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 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

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Atosiban group

Participants allocated to the Atosiban group will be administered Atosiban

Group Type: EXPERIMENTAL

Atosiban

Intervention Type: 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 group

Participants allocated to the placebo group will receive saline infusions.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: DRUG

Participants allocated to the placebo group will receive identical-looking saline infusions for the same duration.

Interventions

Atosiban

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.

Intervention Type: DRUG

Placebo Control

Participants allocated to the placebo group will receive identical-looking saline infusions for the same duration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Scheduled for single blastocyst-stage embryo transfer, either in a fresh or frozen transfer cycle;

2. Have a history of one or more episodes of implantation failures in previous embryo transfer cycles;

3. Age between 20 and 40 years (inclusive);

4. Exhibit abnormal uterine peristalsis on transvaginal ultrasound performed on the morning of the scheduled blastocyst transfer, defined as either: high-frequency peristalsis (>4 contractions per minute), or a negative wave pattern (fundus-to-cervix direction) at any frequency.

5. Each woman could only participate in one transfer cycle.

Exclusion Criteria

1. Immunologic or endocrine disorders including thyroid dysfunction, antiphospholipid syndrome, hyperprolactinemia and other severe systematic diseases (e.g., hypertension, diabetes, etc.)

2. Uterine malformations (e.g., intrauterine adhesions; unicornuate, bicornuate or septate uterus)；

3. Untreated hydrosalpinx or endometrial polyp；

4. Cycles that included in-vitro maturation or oocyte donation；

5. Prior participation in Atosiban 1 study；

6. Current participation in any other clinical trial；

7. Inability to provide informed consent to the study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

OTHER

Sponsor Role: lead

Responsible Party

He Cai

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juanzi Shi, Doctor

Role: STUDY_CHAIR

Center for Reproductive Medicine, Northwest Women's and children's Hospital, Xi'an, shaanxi. china

Locations

Center for Reproductive Medicine, Northwest Women's and Children's Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Cai

Role: CONTACT

caihe@bjmu.edu.cn

13581613908

Facility Contacts

Juanzi Prof Shi, MD

Role: primary

shijuanziart@163.com

+8613581613908

Other Identifiers

2025-058-02

Identifier Type: -

Identifier Source: org_study_id