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The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients

NCT04709796 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2024-04-12

No results posted yet for this study

Summary

This is a pilot study with the aim to investigate the beneficial effect of bicarbonate buffered medium containing hyaluronan and recombinant human albumin (EmbryoGlue®, Vitrolife) in patients with documented repeated implantation failure on live birth per randomized subject as primary endpoint.

Conditions

  • IVF
  • Embryo Loss
  • Miscarriage, Recurrent

Interventions

DRUG

EmbryoGlue®, Vitrolife

The intervention under study is the application of EmbryoGlue®, a class III medical device (CE Marked). EmbryoGlue® is a bicarbonate buffered medium containing recombinant human albumin, hyaluronan and gentamicin as an antibacterial agent.

DRUG

Conventional Transfer

The control arm is the conventional embryo transfer without Embryo glue medium

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Dominic Stoop, MD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04709796 on ClinicalTrials.gov