Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Hyaluronic Acid concentrations (0.5 mg/ml), Low Hyaluronic Acid concentrations (0.125 mg/ml).
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Hyaluronic Acid-enriched Transfer Medium in Women Undergoing Single Blastocyst Transfer : a Multicenter, Randomized Controlled Trial
Overview
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
- Biological High Hyaluronic Acid concentrations (0.5 mg/ml)
Hyaluronic Acid(EmbryoGlue®) - Biological Low Hyaluronic Acid concentrations (0.125 mg/ml)
Hyaluronic Acid (G2 medium)
Primary outcome measures
- Live birth rate [Time frame: Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Uterine anatomic anomalies
- Women with untreated hydrosalpines
- Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- IVF laboratory — Xi'an
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. PMID 41263844
Identifiers
NCT: NCT06492785 · 2024-127