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RecruitingNCT06165367GluePloidUpdated Jun 25, 2026

Hyaluronan-enriched Medium and Euploid Blastocyst Transfers

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

Phase
Not applicable
Study type
Interventional
Enrollment
783
Allocation
Randomized
Ages
18 Years to 46 Years
Sex
Female
01

Study summary

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.

Read the detailed 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).

02

Conditions studied

  • Infertility
  • Implantation Rate
  • Clinical Pregnancy Rate
  • Live Birth Rate
  • Blastocysts
  • FET

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Keywords

  • HRT
  • PGT-A
  • Next-generation sequencing (NGS)
  • Miscarriage rate
  • single embryo transfer (SET)
  • EmbryoGlue
  • BMI
  • Embryo quality
  • Hyaluronan-enriched medium
  • Transfer medium
03

Who can participate

Ages eligible
18 Years to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
783 participants (estimated)

Study arms

  • No intervention
    Blastocysts exposed to normal media (NEG)

    Blastocysts exposed to routine-in use medium No intervention

  • Active comparator
    Blastocysts exposed to EmbryoGlue (EG)

    Blastocysts exposed to EmbryoGlue

    Drug: EmbryoGlue Medium

Interventions

  • DrugEmbryoGlue Medium

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

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • Gardner DK, Rodriegez-Martinez H, Lane M. Fetal development after transfer is increased by replacing protein with the glycosaminoglycan hyaluronan for mouse embryo culture and transfer. Hum Reprod. 1999 Oct;14(10):2575-80. doi: 10.1093/humrep/14.10.2575. PubMed 10527990 ↗
  • Stojkovic M, Kolle S, Peinl S, Stojkovic P, Zakhartchenko V, Thompson JG, Wenigerkind H, Reichenbach HD, Sinowatz F, Wolf E. Effects of high concentrations of hyaluronan in culture medium on development and survival rates of fresh and frozen-thawed bovine embryos produced in vitro. Reproduction. 2002 Jul;124(1):141-53. PubMed 12090927 ↗
  • Miyano T, Hiro-Oka RE, Kano K, Miyake M, Kusunoki H, Kato S. Effects of hyaluronic acid on the development of 1- and 2-cell porcine embryos to the blastocyst stage in vitro. Theriogenology. 1994;41(6):1299-305. doi: 10.1016/0093-691x(94)90488-5. PubMed 16727484 ↗
  • Schoolcraft W, Lane M, Stevens J, Gardner D. Increased hyaluronannan concentration in the embryo transfer medium results in a signifcant increase in human embryo implantation rate. In American Society for Reproductive Medicine. 2002 Fertility and Sterility
  • Atkinson B, Woodland E. Embryo Glue: The Use of Hyaluronan in Embryo Transfer Media. Semin Reprod Med. 2021 Mar;39(1-02):24-26. doi: 10.1055/s-0041-1730415. Epub 2021 May 25. PubMed 34034352 ↗
  • Valojerdi MR, Karimian L, Yazdi PE, Gilani MA, Madani T, Baghestani AR. Efficacy of a human embryo transfer medium: a prospective, randomized clinical trial study. J Assist Reprod Genet. 2006 May;23(5):207-12. doi: 10.1007/s10815-006-9031-7. Epub 2006 Jun 20. PubMed 16786421 ↗
  • Urman B, Yakin K, Ata B, Isiklar A, Balaban B. Effect of hyaluronan-enriched transfer medium on implantation and pregnancy rates after day 3 and day 5 embryo transfers: a prospective randomized study. Fertil Steril. 2008 Sep;90(3):604-12. doi: 10.1016/j.fertnstert.2007.07.1294. Epub 2007 Oct 23. PubMed 17936283 ↗
  • Hazlett WD, Meyer LR, Nasta TE, Mangan PA, Karande VC. Impact of EmbryoGlue as the embryo transfer medium. Fertil Steril. 2008 Jul;90(1):214-6. doi: 10.1016/j.fertnstert.2007.05.063. Epub 2007 Sep 4. PubMed 17765233 ↗
  • Safari S, Razi MH, Safari S, Razi Y. Routine use of EmbryoGlue((R)) as embryo transfer medium does not improve the ART outcomes. Arch Gynecol Obstet. 2015 Feb;291(2):433-7. doi: 10.1007/s00404-014-3416-0. Epub 2014 Aug 24. PubMed 25151028 ↗
  • Heymann D, Vidal L, Or Y, Shoham Z. Hyaluronic acid in embryo transfer media for assisted reproductive technologies. Cochrane Database Syst Rev. 2020 Sep 2;9(9):CD007421. doi: 10.1002/14651858.CD007421.pub4. PubMed 32876946 ↗
  • Child et al. A rCT assessing effectiveness of embryoglue in IVF transfer cycles. ASRM abstract 2021.
  • Adeniyi T, Horne G, Ruane PT, Brison DR, Roberts SA. Clinical efficacy of hyaluronate-containing embryo transfer medium in IVF/ICSI treatment cycles: a cohort study. Hum Reprod Open. 2021 Mar 3;2021(1):hoab004. doi: 10.1093/hropen/hoab004. eCollection 2021. PubMed 33718621 ↗
  • Good practice for recommendation for add-ons in reproductive medicine. ESHRE-working group, 2023.
  • Oron G, Son WY, Buckett W, Tulandi T, Holzer H. The association between embryo quality and perinatal outcome of singletons born after single embryo transfers: a pilot study. Hum Reprod. 2014 Jul;29(7):1444-51. doi: 10.1093/humrep/deu079. Epub 2014 May 8. PubMed 24812313 ↗
  • Vinals Gonzalez X, Odia R, Naja R, Serhal P, Saab W, Seshadri S, Ben-Nagi J. Euploid blastocysts implant irrespective of their morphology after NGS-(PGT-A) testing in advanced maternal age patients. J Assist Reprod Genet. 2019 Aug;36(8):1623-1629. doi: 10.1007/s10815-019-01496-9. Epub 2019 Jun 4. PubMed 31165389 ↗
  • Capalbo A, Rienzi L, Cimadomo D, Maggiulli R, Elliott T, Wright G, Nagy ZP, Ubaldi FM. Correlation between standard blastocyst morphology, euploidy and implantation: an observational study in two centers involving 956 screened blastocysts. Hum Reprod. 2014 Jun;29(6):1173-81. doi: 10.1093/humrep/deu033. Epub 2014 Feb 26. PubMed 24578475 ↗
  • Irani M, Reichman D, Robles A, Melnick A, Davis O, Zaninovic N, Xu K, Rosenwaks Z. Morphologic grading of euploid blastocysts influences implantation and ongoing pregnancy rates. Fertil Steril. 2017 Mar;107(3):664-670. doi: 10.1016/j.fertnstert.2016.11.012. Epub 2017 Jan 6. PubMed 28069172 ↗
  • Li N, Guan Y, Ren B, Zhang Y, Du Y, Kong H, Zhang Y, Lou H. Effect of Blastocyst Morphology and Developmental Rate on Euploidy and Live Birth Rates in Preimplantation Genetic Testing for Aneuploidy Cycles With Single-Embryo Transfer. Front Endocrinol (Lausanne). 2022 Apr 13;13:858042. doi: 10.3389/fendo.2022.858042. eCollection 2022. PubMed 35498424 ↗
  • Xiao Y, Wang X, Gui T, Tao T, Xiong W. Transfer of a poor-quality along with a good-quality embryo on in vitro fertilization/intracytoplasmic sperm injection-embryo transfer clinical outcomes: a systematic review and meta-analysis. Fertil Steril. 2022 Dec;118(6):1066-1079. doi: 10.1016/j.fertnstert.2022.08.848. Epub 2022 Oct 14. PubMed 36244848 ↗
  • Brosens JJ, Salker MS, Teklenburg G, Nautiyal J, Salter S, Lucas ES, Steel JH, Christian M, Chan YW, Boomsma CM, Moore JD, Hartshorne GM, Sucurovic S, Mulac-Jericevic B, Heijnen CJ, Quenby S, Koerkamp MJ, Holstege FC, Shmygol A, Macklon NS. Uterine selection of human embryos at implantation. Sci Rep. 2014 Feb 6;4:3894. doi: 10.1038/srep03894. PubMed 24503642 ↗
  • C. Jennison and B. W. Turnbull, "Group Sequential Methods with Applications to Clinical Trials," Chapman & Hall/CRC, Boca Raton, 2000.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT06165367
Lead sponsor
ART Fertility Clinics LLC
Responsible party
Daniela Nogueira (Global Scientific Laboratory Director ART Fertility Clinics, ART Fertility Clinics LLC) — Principal investigator
First posted
Dec 11, 2023
Start date
Jan 15, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 25, 2026

Study contacts

Daniela Nogueira
Contact
daniela.nogueira@artfertilityclinics.com
+971504374961
Jonalyn DV Edades, Nursing
Contact
jonalyn.edades@artfertilityclinics.com
+97152640866

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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