Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Status: Enrolling

Conditions: Infertility

Treatments: Biological: High Hyaluronic Acid concentrations (0.5 mg/ml); Biological: Low Hyaluronic Acid concentrations (0.125 mg/ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT06492785

2024-127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 858 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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858 participants in 2 patient groups

Hyaluronic Acid(EmbryoGlue®)

Experimental group

Description:

High HA concentrations (0.5 mg/ml)

Treatment:

Biological: High Hyaluronic Acid concentrations (0.5 mg/ml)

Hyaluronic Acid (G2 medium)

Active Comparator group

Description:

Low HA concentrations (0.125 mg/ml)

Treatment:

Biological: Low Hyaluronic Acid concentrations (0.125 mg/ml)