Hyaluronan-enriched Medium and Euploid Blastocyst Transfers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EmbryoGlue Medium.
- Who it may be relevant to
- Registry conditions: Infertility, Implantation Rate, Clinical Pregnancy Rate, Live Birth Rate. Basic parameters: 18 years — 46 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Hyaluronan-enriched Medium on Pregnancy Outcomes Following Euploid Blastocyst Transfers
Overview
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.
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).
Interventions
- Drug EmbryoGlue Medium
Embryos will be exposed to hyaluronic-enriched media (EmbryoGlue) before and during embryo transfer
Primary outcome measures
- Live birth rate (LBR) [Time frame: 41 weeks]
Secondary outcome measures (4)
- human chorionic gonadotropin (hCG) positiveness [Time frame: 10-12 days after embryo transfer]
- Clinical pregnancy rate [Time frame: 6 weeks]
- Clinical miscarriage rate [Time frame: 24 weeks]
- Ongoing pregnancy rate after 12 weeks [Time frame: 13 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United Arab Emirates · 1 center
- ART Fertility Clinics LLC — Abu Dhabi
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 17765233
Identifiers
NCT: NCT06165367 · ART FERTILITY CLINICS