InfertilityNCT06492785
Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer
A study testing High Hyaluronic Acid concentrations (0.5 mg/ml) and Low Hyaluronic Acid concentrations (0.125 mg/ml) in people with Infertility, run by Northwest Women's and Children's Hospital, Xi'an, Shaanxi at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility
- What is being tested?
- High Hyaluronic Acid concentrations (0.5 mg/ml) and Low Hyaluronic Acid concentrations (0.125 mg/ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 858 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2024to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All cycles with single blastocyst transfer will be considered eligible
- Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes
- No age restriction will be applied
- Informed consent was signed
Who cannot join
- Uterine anatomic anomalies
- Women with untreated hydrosalpines
- Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.
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
IVF laboratory
Xi'an, Shaanxi, 710003
Juanzi Prof Shi, MD, +8613581613908, juanzishiart@163.com
About this study
Official title: Use of Hyaluronic Acid-enriched Transfer Medium in Women Undergoing Single Blastocyst Transfer : a Multicenter, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- High Hyaluronic Acid concentrations (0.5 mg/ml), Low Hyaluronic Acid concentrations (0.125 mg/ml)
- Keywords
- Hyaluronate-enriched medium, live birth, Single blastocyst transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Hyaluronic Acid concentrations (0.5 mg/ml)Biological
Hyaluronic Acid(EmbryoGlue®)
Low Hyaluronic Acid concentrations (0.125 mg/ml)Biological
Hyaluronic Acid (G2 medium)
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid(EmbryoGlue®) | Experimental | High HA concentrations (0.5 mg/ml) Receives: Biological: High Hyaluronic Acid concentrations (0.5 mg/ml) |
| Hyaluronic Acid (G2 medium) | Active comparator | Low HA concentrations (0.125 mg/ml) Receives: Biological: Low Hyaluronic Acid concentrations (0.125 mg/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
The primary outcome was Live birth rate per embryo transfer.
Measured: Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.
Secondary outcomes (23)
Biochemical pregnancy
Biochemical pregnancy is defined as serum beta-human chorionic gonadotropin β-hCG > 20 IU/L 12 days after embryo transfer.
Measured: 12 days after embryo transfer.
Clinical pregnancy
Clinical pregnancy is defined as the presence of at least one gestational sac confirmed by ultrasonography (ectopic pregnancy is included as a clinical pregnancy).
Measured: 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.
Measured: after 12 weeks of gestation.
Miscarriage
Miscarriage is defined as spontaneous loss of an intrauterine pregnancy before 20 completed weeks of gestation.
Measured: 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.
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 fetal heartbeats at 7 weeks of gestation.
Measured: 7 weeks of gestation.
hypertensive disorders in pregnancy
Comprising essential hypertension; pregnancy induced hypertension; pre-eclampsia and eclampsia.
Measured: 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
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
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
Measured: Before 37 weeks of gestation and before the onset of labor
Mode of delivery
Vaginal delivery or cesarean delivery
Measured: At birth
Gestational age
Gestational age recorded at delivery
Measured: At birth
Birth weight
Weight of baby born (grams)
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
Mean birth weight
By checking medical records
Measured: 1 year after embryo transfer
Macrosomia
Weight of baby born > 4000 g
Measured: At birth
Large for gestational age
Birthweight > 90th percentile
Measured: At birth
Small for gestational age
Birthweight < 10th percentile
Measured: At birth
Neonatal intensive care unit admission
Safety outcome. Number of pregnancies for which newborn is admitted to the NICU
Measured: Birth up to 1 year
Stillbirth or late fetal death
Fetal death at 20 or more weeks' gestation
Measured: At birth
Early neonatal death
Measured: Up to 28 days after birth
Congenital anomaly or birth defect
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 posted9 Jul 2024
- Study start13 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 858 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Maternal and Child Health Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Huazhong University of Science and Technology
- 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
- NCT06492785
- Sponsor's protocol ID
- 2024-127
- Status last verified
- Nov 2025
- First submitted
- 1 Jul 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41263844
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hyaluronic Acid-enriched Transfer Medium in Women Undergoing Single Blastocyst Transfer : a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06492785
- Acronym / sponsor ID
- 2024-127
- Conditions
- Infertility
- Keywords
- Hyaluronate-enriched medium, live birth, Single blastocyst transfer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 858 participants (estimated)
- Lead sponsor
- Northwest Women's and Children's Hospital, Xi'an, ShaanxiUniversity, hospital or other
- Collaborators
- Jiangxi Maternal and Child Health Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Huazhong University of Science and Technology
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid(EmbryoGlue®) | Experimental | Biological: High Hyaluronic Acid concentrations (0.5 mg/ml)High HA concentrations (0.5 mg/ml) |
| Hyaluronic Acid (G2 medium) | Active comparator | Biological: Low Hyaluronic Acid concentrations (0.125 mg/ml)Low HA concentrations (0.125 mg/ml) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All cycles with single blastocyst transfer will be considered eligible
- Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes
- No age restriction will be applied
- Informed consent was signed
Key exclusion criteria (3 listed)
- Uterine anatomic anomalies
- Women with untreated hydrosalpines
- Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.
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 |
|---|---|---|
| High Hyaluronic Acid concentrations (0.5 mg/ml)Hyaluronic Acid(EmbryoGlue®) | Biological | Hyaluronic Acid(EmbryoGlue®) |
| Low Hyaluronic Acid concentrations (0.125 mg/ml)Hyaluronic Acid (G2 medium) | Biological | Hyaluronic Acid (G2 medium) |
Primary outcome
Live birth rate
Time frame: 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.
23 secondary outcomes
Biochemical pregnancy
Time frame: 12 days after embryo transfer.
Clinical pregnancy
Time frame: 6-8 weeks after embryo transfer
Ongoing pregnancy
Time frame: after 12 weeks of gestation.
Miscarriage
Time frame: 20 weeks of gestation.
Ectopic pregnancy
Time frame: After 4 to 6 weeks of embryo transfer
Multiple pregnancy
Time frame: 7 weeks of gestation.
hypertensive disorders in pregnancy
Time frame: From 20 weeks of gestation up to at birth
Placental implantation disorders
Time frame: From 20 weeks of gestation up to at birth
Preterm birth
Time frame: At birth
Preterm premature rupture of membranes
Time frame: Before 37 weeks of gestation and before the onset of labor
Mode of delivery
Time frame: At birth
Gestational age
Time frame: At birth
Birth weight
Time frame: At birth
low birth weight
Time frame: At birth
Very low birth weight
Time frame: At birth
Mean birth weight
Time frame: 1 year after embryo transfer
Macrosomia
Time frame: At birth
Large for gestational age
Time frame: At birth
Small for gestational age
Time frame: At birth
Neonatal intensive care unit admission
Time frame: Birth up to 1 year
Stillbirth or late fetal death
Time frame: At birth
Early neonatal death
Time frame: Up to 28 days after birth
Congenital anomaly or birth defect
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 5 Dec 2025.
- Derived from this study: PubMed 41263844Cai 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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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 High Hyaluronic Acid concentrations (0.5 mg/ml) and Low Hyaluronic Acid concentrations (0.125 mg/ml) 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 4 inclusion and 3 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 5 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. 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, Doctor (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 rate (time frame: Live birth is defined as the birth of at least one live baby 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 NCT06492785, 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 5 Dec 2025.