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

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: IVF; Embryo Loss; Miscarriage, Recurrent

Treatments: Drug: EmbryoGlue®, Vitrolife; Drug: Conventional Transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT04709796

BC-08429

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 2 patient groups

Intervention group: EmbryoGlue

Experimental group

Description:

Embryo transfer with EmbryoGlue®

Treatment:

Drug: EmbryoGlue®, Vitrolife

Control group

Active Comparator group

Description:

Conventional embryo transfer

Treatment:

Drug: Conventional Transfer