InfertilityNCT07185230
Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions
A study testing Atosiban in people with Infertility, run by Northwest Women's and Children's Hospital, Xi'an, Shaanxi at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Atosiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 792 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Immunologic or endocrine disorders including thyroid dysfunction, antiphospholipid syndrome, hyperprolactinemia and other severe systematic diseases (e.g., hypertension, diabetes, etc.)
- Uterine malformations (e.g., intrauterine adhesions; unicornuate, bicornuate or septate uterus)；
- Untreated hydrosalpinx or endometrial polyp；
- Cycles that included in-vitro maturation or oocyte donation；
- Prior participation in Atosiban 1 study；
- Current participation in any other clinical trial；
- Inability to provide informed consent to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Center for Reproductive Medicine, Northwest Women's and Children's Hospital
Xi'an, Shaanxi, 710003
Juanzi Prof Shi, MD, +8613581613908, shijuanziart@163.com
About this study
Official title: 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 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.
Read more
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
- Being tested
- Atosiban, Placebo Control
- Keywords
- Atosiban
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtosibanDrug
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 ControlDrug
Participants allocated to the placebo group will receive identical-looking saline infusions for the same duration.
| Study group | Role | What they receive |
|---|---|---|
| Atosiban group | Experimental | Participants allocated to the Atosiban group will be administered Atosiban Receives: Drug: Atosiban |
| Placebo group | Placebo comparator | Participants allocated to the placebo group will receive saline infusions. Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Live birth is defined as the delivery of at least one newborn who exhibits any sign of life.
Measured: After 24 weeks of gestation
Secondary outcomes (17)
Biochemical pregnancy
Biochemical pregnancy is defined as serum beta-human chorionic gonadotropin β-hCG> 10 IU/L 12 days after blastocyst transfer.
Measured: 12 days after blastocyst transfer
Clinical pregnancy
Clinical pregnancy is defined as observed gestational sac or definitive clinical signs of pregnancy observed at ultrasonography (including clinically documented ectopic pregnancy)
Measured: 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.
Measured: After 12 weeks of gestation
Miscarriage
Miscarriage is defined as spontaneous loss of an intrauterine pregnancy prior to 20 completed weeks of gestational age.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 28 weeks of pregnancy
hypertensive disorders of pregnancy
Measured: 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
Measured: At birth
low birth weight
Weight of baby born < 2500 g
Measured: At birth
Very low birth weight
Weight of baby born < 1500 g
Measured: At birth
high birth weight
Weight of baby born > 4000 g
Measured: 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
Measured: 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.
Measured: at birth
Early neonatal death
Early neonatal death refers to death of a live born baby within 7days of birth
Measured: within 7days of birth
Congenital anomaly
Any congenital anomalies detected in baby born
Measured: Birth to first year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start6 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Cai, Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Investigators
- Juanzi Shi, Doctor, Study chair, Center for Reproductive Medicine, Northwest Women's and children's Hospital, Xi'an, shaanxi. china
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185230
- Sponsor's protocol ID
- 2025-058-02
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42229962
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions Undergoing Single Blastocyst-Stage Embryo Transfer: A Randomised Triple-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07185230
- Acronym / sponsor ID
- 2025-058-02
- Conditions
- Infertility
- Keywords
- Atosiban
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 792 participants (estimated)
- Lead sponsor
- Northwest Women's and Children's Hospital, Xi'an, ShaanxiUniversity, hospital or other
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atosiban group | Experimental | Drug: AtosibanParticipants allocated to the Atosiban group will be administered Atosiban |
| Placebo group | Placebo comparator | Drug: Placebo ControlParticipants allocated to the placebo group will receive saline infusions. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Immunologic or endocrine disorders including thyroid dysfunction, antiphospholipid syndrome, hyperprolactinemia and other severe systematic diseases (e.g., hypertension, diabetes, etc.)
- Uterine malformations (e.g., intrauterine adhesions; unicornuate, bicornuate or septate uterus)；
- Untreated hydrosalpinx or endometrial polyp；
- Cycles that included in-vitro maturation or oocyte donation；
- Prior participation in Atosiban 1 study；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtosibanParticipants 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. | Drug | Atosiban group |
| Placebo ControlParticipants allocated to the placebo group will receive identical-looking saline infusions for the same duration. | Drug | Placebo group |
Primary outcome
Live birth
Time frame: After 24 weeks of gestation
Live birth is defined as the delivery of at least one newborn who exhibits any sign of life.
17 secondary outcomes
Biochemical pregnancy
Time frame: 12 days after blastocyst transfer
Clinical pregnancy
Time frame: 6-8 weeks after blastocyst transfer.
Ongoing pregnancy
Time frame: After 12 weeks of gestation
Miscarriage
Time frame: before 20 weeks of gestation.
Stillbirth
Time frame: after 20 weeks of gestation
Ectopic pregnancy
Time frame: After 4 to 6 weeks of embryo transfer
Multiple pregnancy
Time frame: 7 weeks of gestation
Gestational diabetes mellitus
Time frame: At 28 weeks of pregnancy
hypertensive disorders of pregnancy
Time frame: From 20 weeks of gestation up to at birth
preterm birth
Time frame: At birth
low birth weight
Time frame: At birth
Very low birth weight
Time frame: At birth
high birth weight
Time frame: at birth
large for gestational age
Time frame: at birth
small for gestational age
Time frame: at birth
Early neonatal death
Time frame: within 7days of birth
Congenital anomaly
Time frame: Birth to first year of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 42229962Cai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juanzi Shi, Doctor study chair
Center for Reproductive Medicine, Northwest Women's and children's Hospital, Xi'an, shaanxi. china
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atosiban in people with Infertility, run by Northwest Women's and Children's Hospital, Xi'an, Shaanxi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Cai (13581613908, caihe@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: After 24 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07185230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.