Infertility
Conditions
Keywords
Hyaluronate-enriched medium, live birth, Single blastocyst transfer
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALHigh Hyaluronic Acid concentrations (0.5 mg/ml)
Hyaluronic Acid(EmbryoGlue®)
BIOLOGICALLow Hyaluronic Acid concentrations (0.125 mg/ml)
Hyaluronic Acid (G2 medium)
Sponsors
Jiangxi Maternal and Child Health Hospital
Gansu Provincial Maternal and Child Health Care Hospital
Huazhong University of Science and Technology
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. All cycles with single blastocyst transfer will be considered eligible 2. Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes 3. No age restriction will be applied 4. Informed consent was signed
Exclusion criteria
1. Uterine anatomic anomalies 2. Women with untreated hydrosalpines 3. Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate | Live birth is defined as the birth of at least one live baby after 24 weeks of gestation. | The primary outcome was Live birth rate per embryo transfer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy | 12 days after embryo transfer. | Biochemical pregnancy is defined as serum beta-human chorionic gonadotropin β-hCG \> 20 IU/L 12 days after embryo transfer. |
| Clinical pregnancy | 6-8 weeks after embryo transfer | Clinical pregnancy is defined as the presence of at least one gestational sac confirmed by ultrasonography (ectopic pregnancy is included as a clinical pregnancy). |
| Ongoing pregnancy | after 12 weeks of gestation. | Ongoing pregnancy is defined as the presence of a gestational sac and fetal heartbeat after 12 weeks of gestation. |
| Miscarriage | 20 weeks of gestation. | Miscarriage is defined as spontaneous loss of an intrauterine pregnancy before 20 completed weeks of gestation. |
| Ectopic pregnancy | After 4 to 6 weeks of embryo transfer | Ectopic pregnancy is defined as a pregnancy implanted outside the uterine cavity, diagnosed by ultrasonography, surgical visualization, or histopathology. |
| Multiple pregnancy | 7 weeks of gestation. | Multiple pregnancy is defined as a pregnancy with two or more gestational sacs or fetal heartbeats at 7 weeks of gestation. |
| hypertensive disorders in pregnancy | From 20 weeks of gestation up to at birth | Comprising essential hypertension; pregnancy induced hypertension; pre-eclampsia and eclampsia. |
| Placental implantation disorders | From 20 weeks of gestation up to at birth | Placental implantation disorders encompass placenta previa, placenta accreta spectrum, placental abruption and/or abnormal cord insertion |
| Preterm birth | At birth | Delivery of a fetus at less than 37 and more than 28 weeks gestational age |
| Preterm premature rupture of membranes | Before 37 weeks of gestation and before the onset of labor | 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 |
| Mode of delivery | At birth | Vaginal delivery or cesarean delivery |
| Gestational age | At birth | Gestational age recorded at delivery |
| Birth weight | At birth | Weight of baby born (grams) |
| low birth weight | At birth | Weight of baby born \< 2500 g |
| Very low birth weight | At birth | Weight of baby born \< 1500 g |
| Mean birth weight | 1 year after embryo transfer | By checking medical records |
| Macrosomia | At birth | Weight of baby born \> 4000 g |
| Large for gestational age | At birth | Birthweight \> 90th percentile |
| Small for gestational age | At birth | Birthweight \< 10th percentile |
| Neonatal intensive care unit admission | Birth up to 1 year | Safety outcome. Number of pregnancies for which newborn is admitted to the NICU |
| Stillbirth or late fetal death | At birth | Fetal death at 20 or more weeks' gestation |
| Early neonatal death | Up to 28 days after birth | — |
| Congenital anomaly or birth defect | Birth to first year of life | Any congenital anomalies detected in baby born |
Countries
China
Contacts
Primary ContactHe Cai, Doctor
Outcome results
None listed