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

Not Applicable

Recruiting

• Conditions: IVF; Embryo Loss; Miscarriage, Recurrent
• Interventions: Drug: EmbryoGlue®, Vitrolife; Drug: Conventional Transfer

• Registration Number: NCT04709796
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Study Start: 2021-03-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: EmbryoGlue	EmbryoGlue®, Vitrolife	Embryo transfer with EmbryoGlue®
Control group	Conventional Transfer	Conventional embryo transfer

Primary Outcome Measures

Name	Time	Method
Live birth	9 months after embryo transfer	live birth per randomized subject.

Secondary Outcome Measures

Name	Time	Method
positive hCG	11 days (± 2 days) after embryo transfer.	cumulative positive hCG rate confirmed by blood sample
ongoing pregnancy rate	between 6 and 8 weeks of gestation	cumulative ongoing pregnancy rate per randomized subject, confirmed by ultrasound

Trial Locations

Locations (1)

UZ Ghent; 🇧🇪 Ghent, Belgium