Atosiban for women with prior implantation failure and abnormal uterine contractions
Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions Undergoing Single Blastocyst-Stage Embryo Transfer: A Randomised Triple-Blind, Placebo-Controlled Trial
This trial tests whether giving atosiban around the time of a single blastocyst transfer helps women aged 20–40 with prior implantation failures and abnormal uterine contractions have more live births.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 792 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Northwest Women's and Children's Hospital, Xi'an, Shaanxi Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07185230 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled study enrolls infertile women aged 20–40 scheduled for a single blastocyst transfer (fresh or frozen) who have a history of implantation failure and show abnormal uterine peristalsis on ultrasound. Participants will be randomized to receive atosiban or a matching placebo around the time of embryo transfer, with each woman participating in only one transfer cycle. The primary outcome is live birth rate from the treated cycle; secondary outcomes include perinatal and neonatal complications and safety outcomes such as miscarriage and ectopic pregnancy rates. Uterine peristalsis is defined in this trial as high-frequency contractions (>4 contractions per minute) or a negative fundus-to-cervix wave pattern on the morning of transfer, and the trial is conducted at the Center for Reproductive Medicine, Northwest Women's and Children's Hospital in Xi'an, Shaanxi.
Who should consider this trial
Good fit: Women aged 20–40 undergoing a single blastocyst transfer (fresh or frozen) who have one or more prior implantation failures and demonstrate abnormal uterine peristalsis on the morning of transfer are the intended participants.
Not a fit: Women with major systemic, immunologic, or endocrine disorders (for example uncontrolled thyroid disease, antiphospholipid syndrome, severe hypertension or diabetes) or those without abnormal uterine contractions are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, using atosiban at embryo transfer could increase the chance of a live birth for women with prior implantation failure and abnormal uterine contractions.
How similar studies have performed: Earlier, smaller studies and prior atosiban trials have shown mixed but sometimes encouraging signals that atosiban can improve implantation or pregnancy outcomes in selected patients, making this targeted placebo-controlled trial a logical next step.
Eligibility criteria
Show full inclusion / exclusion criteria
Participants/eligibility criteria Infertile women who fulfill all of the following inclusion criteria, based on the results and findings of the Atosiban 1 study are eligible for participation: 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.
Where this trial is running
Xi'an, Shaanxi
- Center for Reproductive Medicine, Northwest Women's and Children's Hospital — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: He Cai
- Email: caihe@bjmu.edu.cn
- Phone: 13581613908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.