Status:
RECRUITING
The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients
Lead Sponsor:
University Hospital, Ghent
Conditions:
IVF
Embryo Loss
Eligibility:
FEMALE
18-40 years
Phase:
NA
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 doc...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT04709796
Start Date
March 3 2021
End Date
June 30 2025
Last Update
April 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UZ Ghent
Ghent, Belgium, 9000