NCT04709796

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

3.8 years

First QC Date

December 16, 2020

Last Update Submit

April 11, 2024

Conditions

IVFEmbryo LossMiscarriage, Recurrent

Outcome Measures

Primary Outcomes (1)

  • Live birth

    live birth per randomized subject.

    9 months after embryo transfer

Secondary Outcomes (2)

  • positive hCG

    11 days (± 2 days) after embryo transfer.

  • ongoing pregnancy rate

    between 6 and 8 weeks of gestation

Study Arms (2)

Intervention group: EmbryoGlue

EXPERIMENTAL

Embryo transfer with EmbryoGlue®

Drug: EmbryoGlue®, Vitrolife

Control group

ACTIVE COMPARATOR

Conventional embryo transfer

Drug: Conventional Transfer

Interventions

EmbryoGlue®, VitrolifeDRUG

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.

Intervention group: EmbryoGlue
Conventional TransferDRUG

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

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The trial only includes women with a clinical indication for ART with a history of RIF defined as the absence of implantation after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos was no less than four for cleavage-stage embryos and no less than two for blastocysts, with all embryos being of good quality and of appropriate developmental stage.
  • Furthermore, other specific 'RIF' investigations were performed and treated if necessary:
  • Normal hysteroscopy
  • Normal karyotype of both parents
  • Coagulation screening (Antitrombine II deficiency, Factor VIII augmentation, APC resistance, Factor V + Factor II augmentation, Protein S and C deficiency an homocysteine augmentation)
  • Auto-immune screening (Lupus anticoagulant, Rheumatoid Factor, Anti-nuclear antibodies, Anti-cardiolipine antibodies and Glycoprotein-1-antibodies)

You may not qualify if:

  • Simultaneous participation in another clinical study
  • Untreated and uncontrolled thyroid dysfunction
  • Tumors of the ovary, breast, uterus, pituitary or hypothalamus
  • Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
  • Ovarian cysts or enlarged ovaries
  • Malformations of the reproductive organs
  • Moderate or severe hepatic impairment
  • Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy
  • Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation
  • Couples needing TESE/MESA material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Embryo LossAbortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dominic Stoop, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

January 14, 2021

Study Start

March 3, 2021

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations

BE(1)