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

IVF Clinical Trial

— RIFLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709796
• Other study ID #: BC-08429
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Embryo Loss
• IVF
• Miscarriage, Recurrent

Intervention

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.
• Conventional Transfer
The control arm is the conventional embryo transfer without Embryo glue medium

Locations

Country	Name	City	State
Belgium	UZ Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth	live birth per randomized subject.	9 months after embryo transfer
Secondary	positive hCG	cumulative positive hCG rate confirmed by blood sample	11 days (± 2 days) after embryo transfer.
Secondary	ongoing pregnancy rate	cumulative ongoing pregnancy rate per randomized subject, confirmed by ultrasound	between 6 and 8 weeks of gestation