Using hyaluronan-enriched medium to improve embryo transfer outcomes
Impact of Hyaluronan-enriched Medium on Pregnancy Outcomes Following Euploid Blastocyst Transfers
NA · ART Fertility Clinics LLC · NCT06165367
This study is testing if using a special gel called EmbryoGlue during frozen embryo transfers can help women with healthy embryos get pregnant more successfully.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 783 (estimated) |
| Ages | 18 Years to 46 Years |
| Sex | Female |
| Sponsor | ART Fertility Clinics LLC (other) |
| Locations | 1 site (Abu Dhabi, Abu Dhabi Emirate) |
| Trial ID | NCT06165367 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a hyaluronan-enriched medium, known as EmbryoGlue, on the pregnancy outcomes of euploid blastocyst transfers during frozen embryo transfer (FET) cycles. The trial will involve women aged 18 to 46 who have undergone preimplantation genetic testing for aneuploidy (PGT-A) and have at least one chromosomally normal blastocyst available for transfer. The study is designed to be double-blinded, ensuring that both patients and doctors are unaware of the treatment being administered. The primary goal is to determine if exposure to EmbryoGlue prior to and during transfer enhances implantation rates and overall pregnancy success. Interim analyses will be conducted to assess the trial's progress and efficacy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 46 with at least one euploid blastocyst available for transfer and undergoing hormonal replacement therapy.
Not a fit: Patients with mosaic or aneuploid blastocysts, or those undergoing genetic testing for monogenic disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pregnancy rates for women undergoing embryo transfers.
How similar studies have performed: While previous studies have explored embryo transfer media, this specific approach using hyaluronan-enriched medium in conjunction with PGT-A is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Abu Dhabi, Abu Dhabi Emirate
- ART Fertility Clinics LLC — Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates (RECRUITING)
Study contacts
- Study coordinator: Daniela Nogueira
- Email: daniela.nogueira@artfertilityclinics.com
- Phone: +971504374961
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, Implantation Rate, Clinical Pregnancy Rate, Live Birth Rate, Blastocysts, FET, HRT, PGT-A