Hyaluronan-enriched Medium and Euploid Blastocyst Transfers (GluePloid)

ART Fertility Clinics LLC

Status

Enrolling

Conditions

Live Birth Rate

Infertility

Clinical Pregnancy Rate

Blastocysts

Implantation Rate

FET

Treatments

Drug: EmbryoGlue Medium

Study type

Interventional

Funder types

Other

Identifiers

NCT06165367

ART FERTILITY CLINICS

Details and patient eligibility

About

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.

Full description

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).

Enrollment

783 estimated patients

Sex

Female

Ages

18 to 46 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All frozen embryo transfer (FET) cycles with euploid blastocysts biopsied and vitrified on Day 5 after PGT-A.
Rank of randomization based on embryo quality.
Only hormonal replacement theraphy (HRT) cycle regimen.
Women aged 18 years to 46 years.
Having at least 1 chromosomally normal vitrified blastocyst(s) on Day 5 available for transfer.
All sperm samples.
BMI between 18 and 35.

Exclusion criteria

FET cycles with preimplantation genetic testing for monogenic disorders (PGT-M) and for structural rearrangements (PGT-SR).
FET cycles with mosaic / aneuploid blastocysts.
FET cycles with unknown outcome.
FET cycles with Day 6 or Day 7 biopsied blastocysts.
FET with patients' endometrium preparation with treatments other than HRT.
FET where PGT-A was performed for gender selection.