Atosiban for women with prior implantation failure and abnormal uterine contractions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.