Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

858 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hyaluronic Acid(EmbryoGlue®)

High HA concentrations (0.5 mg/ml)

Group Type EXPERIMENTAL

High Hyaluronic Acid concentrations (0.5 mg/ml)

Intervention Type BIOLOGICAL

Hyaluronic Acid(EmbryoGlue®)

Hyaluronic Acid (G2 medium)

Low HA concentrations (0.125 mg/ml)

Group Type ACTIVE_COMPARATOR

Low Hyaluronic Acid concentrations (0.125 mg/ml)

Intervention Type BIOLOGICAL

Hyaluronic Acid (G2 medium)

Interventions

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High Hyaluronic Acid concentrations (0.5 mg/ml)

Hyaluronic Acid(EmbryoGlue®)

Intervention Type BIOLOGICAL

Low Hyaluronic Acid concentrations (0.125 mg/ml)

Hyaluronic Acid (G2 medium)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No