Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions

Northwest Women's and Children's Hospital, Xi'an, Shaanxi792 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Interventions

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Live birth

Live birth is defined as the delivery of at least one newborn who exhibits any sign of life.

Time frame: After 24 weeks of gestation

Secondary Outcomes

Biochemical pregnancy

Biochemical pregnancy is defined as serum beta-human chorionic gonadotropin β-hCG\> 10 IU/L 12 days after blastocyst transfer.

Time frame: 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)

Time frame: 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.

Time frame: After 12 weeks of gestation

Miscarriage

Miscarriage is defined as spontaneous loss of an intrauterine pregnancy prior to 20 completed weeks of gestational age.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At 28 weeks of pregnancy

hypertensive disorders of pregnancy

Time frame: 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

Time frame: At birth

low birth weight

Weight of baby born \< 2500 g

Time frame: At birth

Very low birth weight

Weight of baby born \< 1500 g

Time frame: At birth

high birth weight

Weight of baby born \> 4000 g

Time frame: 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

Time frame: 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.

Time frame: at birth

Early neonatal death

Early neonatal death refers to death of a live born baby within 7days of birth

Time frame: within 7days of birth

Congenital anomaly

Any congenital anomalies detected in baby born

Time frame: Birth to first year of life

Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts