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NCT Number: NCT06165367

Hyaluronan-enriched Medium and Euploid Blastocyst Transfers

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.

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Key information

Age range

18 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

Location status: Recruiting

Location contact

Barbara Lawrenz, PhD

CONTACT

[email protected]

+971 800 337845489

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EmbryoGlue Medium

Drug

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

Primary outcomes

  1. Live birth rate (LBR)

    Time frame: 41 weeks

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

Secondary outcomes

  1. human chorionic gonadotropin (hCG) positiveness

    Time frame: 10-12 days after embryo transfer

    hCG pregnancy test checks human chorionic gonadotropin (HCG) levels in the blood.

  2. Clinical pregnancy rate

    Time frame: 6 weeks

    ultrasonographic sac visible at 5 gestational weeks

  3. Clinical miscarriage rate

    Time frame: 24 weeks

    spontaneous loss of a clinical pregnancy before 24 weeks of gestation

  4. Ongoing pregnancy rate after 12 weeks

    Time frame: 13 weeks

    viable pregnancy with gestational age more than 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Nogueira

CONTACT

[email protected]

+971504374961

Jonalyn DV Edades, Nursing

CONTACT

[email protected]

+97152640866

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

Impact of Hyaluronan-enriched Medium on Pregnancy Outcomes Following Euploid Blastocyst Transfers

Acronym: GluePloid

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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