Health TrialsbyHealthPanel

Hyaluronan-enriched Medium and Euploid Blastocyst Transfers

ConditionsInfertilityImplantation RateClinical Pregnancy RateLive Birth RateBlastocystsFET
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-46
SponsorART Fertility Clinics LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EmbryoGlue Medium

    Drug

    Embryos will be exposed to hyaluronic-enriched media (EmbryoGlue) before and during embryo transfer

Treatment groups

783 Participants
are divided into 2 treatment groups
Group A: Blastocysts exposed to normal media (NEG)No intervention 0 interventions
Group B: Blastocysts exposed to EmbryoGlue (EG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Live birth rate (LBR)

Defined as the delivery if a live infant born after 24 completed weeks of gestation

Time frame
41 weeks

Secondary outcomes

1

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
2

Clinical pregnancy rate

ultrasonographic sac visible at 5 gestational weeks

Time frame
6 weeks
3

Clinical miscarriage rate

spontaneous loss of a clinical pregnancy before 24 weeks of gestation

Time frame
24 weeks
4

Ongoing pregnancy rate after 12 weeks

viable pregnancy with gestational age more than 12 weeks

Time frame
13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ART Fertility Clinics LLC

Lead sponsor

Source ClinicalTrials.gov
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