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| Name | Class |
|---|---|
| Jiangxi Maternal and Child Health Hospital | OTHER |
| Gansu Provincial Maternal and Child Health Care Hospital | OTHER |
| Huazhong University of Science and Technology | OTHER |
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The purpose of this study is to compare the live birth rates of high concentration of Hyaluronic Acid (0.5 mg/ml) transfer medium (EmbryoGlue®) to those containing low Hyaluronic Acid concentrations (0.125 mg/ml) (G2 medium) in women undergoing single fresh and frozen blastocyst transfer.
The single blastocyst-stage embryo transfer cycles will be randomised in a 1:1 allocation, with block sizes of 2 and 4 on the day of Embryo Transfer (ET). This randomisation process will be centrally managed via a web-based electronic data capture system and will be stratified according to the treatment center. The allocation sequence and the designated treatment will be completely concealed from the participating couples, clinicians - including those conducting the transfer procedures - and outcome assessors. Given the intrinsic viscous nature of EmbryoGlue, embryologists, who who are responsible for the procedures in the laboratory will not be subjected to blinding. Only at the end of the study, when data collection is completed, the allocation sequence will be revealed to the primary investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid(EmbryoGlue®) | Experimental | High HA concentrations (0.5 mg/ml) |
|
| Hyaluronic Acid (G2 medium) | Active Comparator | Low HA concentrations (0.125 mg/ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Hyaluronic Acid concentrations (0.5 mg/ml) | Biological | Hyaluronic Acid(EmbryoGlue®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | The primary outcome was Live birth rate per embryo transfer. | Live birth is defined as the birth of at least one live baby after 24 weeks of gestation. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical pregnancy | Biochemical pregnancy is defined as serum beta-human chorionic gonadotropin β-hCG > 20 IU/L 12 days after embryo transfer. | 12 days after embryo transfer. |
| Clinical pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Cai, Doctor | 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 |
|---|---|---|---|---|---|---|
| IVF laboratory | Recruiting | Xi'an | Shaanxi | 710003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41263844 | Derived | Cai H, Xu D, Wang Z, Huang B, Xue X, Bai H, Man Y, Lei D, Wu Q, Ni Y, Lei J, Shi J. Efficacy and safety of hyaluronic acid-enriched transfer medium in women undergoing single blastocyst transfer: a study protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Nov 19;15(11):e104571. doi: 10.1136/bmjopen-2025-104571. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Low Hyaluronic Acid concentrations (0.125 mg/ml) | Biological | Hyaluronic Acid (G2 medium) |
|
Clinical pregnancy is defined as the presence of at least one gestational sac confirmed by ultrasonography (ectopic pregnancy is included as a clinical pregnancy).
| 6-8 weeks after embryo 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 before 20 completed weeks of gestation. | 20 weeks of gestation. |
| Ectopic pregnancy | Ectopic pregnancy is defined as a pregnancy implanted outside the uterine cavity, diagnosed by ultrasonography, 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 fetal heartbeats at 7 weeks of gestation. | 7 weeks of gestation. |
| hypertensive disorders in pregnancy | Comprising essential hypertension; pregnancy induced hypertension; pre-eclampsia and eclampsia. | From 20 weeks of gestation up to at birth |
| Placental implantation disorders | Placental implantation disorders encompass placenta previa, placenta accreta spectrum, placental abruption and/or abnormal cord insertion | 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 |
| Preterm premature rupture of membranes | Preterm premature rupture of membranes is defined as the leakage of amniotic fluid through the cervical os before 37 weeks of gestation and before the onset of labor | Before 37 weeks of gestation and before the onset of labor |
| Mode of delivery | Vaginal delivery or cesarean delivery | At birth |
| Gestational age | Gestational age recorded at delivery | At birth |
| Birth weight | Weight of baby born (grams) | 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 |
| Mean birth weight | By checking medical records | 1 year after embryo transfer |
| Macrosomia | Weight of baby born > 4000 g | At birth |
| Large for gestational age | Birthweight > 90th percentile | At birth |
| Small for gestational age | Birthweight < 10th percentile | At birth |
| Neonatal intensive care unit admission | Safety outcome. Number of pregnancies for which newborn is admitted to the NICU | Birth up to 1 year |
| Stillbirth or late fetal death | Fetal death at 20 or more weeks' gestation | At birth |
| Early neonatal death | Up to 28 days after birth |
| Congenital anomaly or birth defect | Any congenital anomalies detected in baby born | Birth to first year of life |