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

NCT ID: NCT04709796

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2025-06-30

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.

Conditions

IVF; Embryo Loss; Miscarriage, Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group: EmbryoGlue

Embryo transfer with EmbryoGlue®

Group Type: EXPERIMENTAL

EmbryoGlue®, Vitrolife

Intervention Type: DRUG

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.

Control group

Conventional embryo transfer

Group Type: ACTIVE_COMPARATOR

Conventional Transfer

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Conventional Transfer

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominic Stoop, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

UZ Ghent

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

Dominic Stoop

Role: primary

dominic.stoop@uzgent.be

09/332.16.99

Other Identifiers

BC-08429

Identifier Type: -

Identifier Source: org_study_id