Using a special medium to help women with repeated IVF failures
The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients
This study is testing if a special substance called EmbryoGlue® can help women who have had trouble getting pregnant through IVF to have a successful pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ghent) |
| Trial ID | NCT04709796 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of a bicarbonate buffered medium containing hyaluronan and recombinant human albumin, known as EmbryoGlue®, in women who have experienced repeated implantation failure (RIF) during assisted reproductive technology (ART). The primary endpoint is the live birth rate per randomized subject. Participants will be women with a documented history of RIF, defined by specific criteria related to previous IVF cycles. The study will compare the outcomes of using EmbryoGlue® versus conventional transfer methods.
Who should consider this trial
Good fit: Ideal candidates for this study are women with a clinical indication for ART who have a documented history of repeated implantation failure.
Not a fit: Patients who have not experienced repeated implantation failure or those with other complicating factors not addressed in the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly improve the chances of live births for women experiencing repeated implantation failures.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with implantation failures.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent
- UZ Ghent — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Dominic Stoop, MD — University Hospital, Ghent
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.