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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atosiban group | Experimental | Participants allocated to the Atosiban group will be administered Atosiban |
|
| Placebo group | Placebo Comparator | Participants allocated to the placebo group will receive saline infusions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | Live birth is defined as the delivery of at least one newborn who exhibits any sign of life. | After 24 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical pregnancy | Biochemical pregnancy is defined as serum beta-human chorionic gonadotropin β-hCG> 10 IU/L 12 days after blastocyst transfer. | 12 days after blastocyst transfer |
| Clinical pregnancy |
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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:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Cai | Contact | 13581613908 | caihe@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Juanzi Shi, Doctor | Center for Reproductive Medicine, Northwest Women's and children's Hospital, Xi'an, shaanxi. china | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Reproductive Medicine, Northwest Women's and Children's Hospital | Recruiting | Xi'an | Shaanxi | 710003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42229962 | Derived | Cai H, Li W, Mol BWJ, Liu D, Lei D, Ran X, Zhang D, Xue X, Gao L, Shi J. Randomised, triple-blind, placebo-controlled trial of atosiban in women with previous embryo implantation failure and abnormal uterine contractions undergoing single blastocyst-stage embryo transfer: a study protocol. BMJ Open. 2026 Jun 2;16(6):e114029. doi: 10.1136/bmjopen-2025-114029. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C047046 | atosiban |
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| Placebo Control | Drug | Participants allocated to the placebo group will receive identical-looking saline infusions for the same duration. |
|
Clinical pregnancy is defined as observed gestational sac or definitive clinical signs of pregnancy observed at ultrasonography (including clinically documented ectopic pregnancy)
| 6-8 weeks after blastocyst transfer. |
| Ongoing pregnancy | Ongoing pregnancy is defined as the presence of a gestational sac and fetal heartbeat after 12 weeks of gestation. | After 12 weeks of gestation |
| Miscarriage | Miscarriage is defined as spontaneous loss of an intrauterine pregnancy prior to 20 completed weeks of gestational age. | before 20 weeks of gestation. |
| Stillbirth | Stillbirth is defined as the death of a fetus prior to the complete expulsion or extraction from its mother after 20 completed weeks of gestational age including deaths during labor. | after 20 weeks of gestation |
| Ectopic pregnancy | Ectopic pregnancy is defined as a pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology. | After 4 to 6 weeks of embryo transfer |
| Multiple pregnancy | Multiple pregnancy is defined as a pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation. | 7 weeks of gestation |
| Gestational diabetes mellitus | Newly diagnosed diabetes or gestational diabetes at 28 weeks of pregnancy confirmed by 75 g oral glucose tolerance test. | At 28 weeks of pregnancy |
| hypertensive disorders of pregnancy | From 20 weeks of gestation up to at birth |
| preterm birth | Delivery of a fetus at less than 37 and more than 28 weeks gestational age | At birth |
| low birth weight | Weight of baby born < 2500 g | At birth |
| Very low birth weight | Weight of baby born < 1500 g | At birth |
| high birth weight | Weight of baby born > 4000 g | at birth |
| large for gestational age | large for gestational age is defined as birth weight greater than 90th percentile for gestation, based on standardised ethnicity-based charts | at birth |
| small for gestational age | small for gestational age is defined as less than 10th percentile for gestational age at delivery based on standardised ethnicity-based charts. | at birth |
| Early neonatal death | Early neonatal death refers to death of a live born baby within 7days of birth | within 7days of birth |
| Congenital anomaly | Any congenital anomalies detected in baby born | Birth to first year of life |