Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

Not Applicable

Recruiting

• Conditions: Infertility
• Interventions: Biological: High Hyaluronic Acid concentrations (0.5 mg/ml); Biological: Low Hyaluronic Acid concentrations (0.125 mg/ml)

• Registration Number: NCT06492785
• Lead Sponsor: Northwest Women's and Children's Hospital, Xi'an, Shaanxi

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.

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2024-09-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 858

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic Acid(EmbryoGlue®)	High Hyaluronic Acid concentrations (0.5 mg/ml)	High HA concentrations (0.5 mg/ml)
Hyaluronic Acid (G2 medium)	Low Hyaluronic Acid concentrations (0.125 mg/ml)	Low HA concentrations (0.125 mg/ml)

Primary Outcome Measures

Name	Time	Method
Live birth rate	Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.	The primary outcome measure was Live birth rate per embryo transfer.

Trial Locations

Locations (1)

IVF laboratory; 🇨🇳 Xi'an, Shaanxi, China