An interventional study of EmbryoGlue Medium in Infertility, Implantation Rate and Clinical Pregnancy Rate, sponsored by ART Fertility Clinics LLC. Recruiting at 1 site in United Arab Emirates. Open to female participants aged 18 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by ART Fertility Clinics LLC · Not applicable, Interventional, and Treatment
It has been proposed that enriching transfer media with hyaluronan (EmbryoGlue medium) improves pregnancy outcomes compared with media containing lower concentrations of this molecule. However, none of previous studies included preimplantation genetic testing for aneuploidy (PGT-A) embryos. In order to investigate the impact of this hyaluronan-enriched on pregnancy outcomes, it is essential to evaluate its efficacy on euploid-only embryo transfers. The aim of the present study is to evaluate whether a short period of exposure of euploid blastocysts to EmbryoGlue prior to and during transfer positively impact on pregnancy outcomes of frozen embryo transfer (FET) cycles.
The study period will be determined by the completion of the predetermined sample size, with two interim analyses planned when 35% (n=274) and 70% (n=548) of the target sample size is achieved to calculate conditional power. If conditional power is estimated to be lower than 15% at first interim analysis or lower than 30% in the second interim analysis, the trial will be stopped due to futility. The study will be performed in Abu Dhabi-Fertility clinic. During the period of this prospective study, euploid blastocysts of enough quality that have been biopsied only on Day-5 for PGT-A, will be warmed for single blastocyst transfer. The patient´s endometrial preparation protocol for FET will be restricted to HRT only. The study will be double-blinded (blinded to patient and doctor performing transfer).
Exclusion Criteria:
Blastocysts exposed to routine-in use medium No intervention
Blastocysts exposed to EmbryoGlue
Drug: EmbryoGlue Medium
Embryos will be exposed to hyaluronic-enriched media (EmbryoGlue) before and during embryo transfer
Live birth rate (LBR)
Defined as the delivery if a live infant born after 24 completed weeks of gestation
Time frame: 41 weeks
human chorionic gonadotropin (hCG) positiveness
hCG pregnancy test checks human chorionic gonadotropin (HCG) levels in the blood.
Time frame: 10-12 days after embryo transfer
Clinical pregnancy rate
ultrasonographic sac visible at 5 gestational weeks
Time frame: 6 weeks
Clinical miscarriage rate
spontaneous loss of a clinical pregnancy before 24 weeks of gestation
Time frame: 24 weeks
Ongoing pregnancy rate after 12 weeks
viable pregnancy with gestational age more than 12 weeks
Time frame: 13 weeks
Plan to share: Undecided
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