Status:
RECRUITING
Hyaluronan-enriched Medium and Euploid Blastocyst Transfers
Lead Sponsor:
ART Fertility Clinics LLC
Conditions:
Infertility
Implantation Rate
Eligibility:
FEMALE
18-46 years
Phase:
NA
Brief 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 o...
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 calc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
783 Patients enrolled
Trial Details
Trial ID
NCT06165367
Start Date
January 15 2024
End Date
December 31 2025
Last Update
March 12 2025
Active Locations (1)
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1
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 60202