NCT06492785

Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

Use of Hyaluronic Acid-enriched Transfer Medium in Women Undergoing Single Blastocyst Transfer : a Multicenter, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 858 (estimated)
• Sponsor: Northwest Women's and Children's Hospital, Xi'an, Shaanxi · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-09-13
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-07-09
• Last updated: 2025-12-05

Locations

1 site across 1 country: China