Clinical trial NCT06165367: Hyaluronan-enriched Medium and Euploid Blastocyst Transfers
Official title: Impact of Hyaluronan-enriched Medium on Pregnancy Outcomes Following Euploid Blastocyst Transfers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Implantation Rate
Clinical Pregnancy Rate
Live Birth Rate
Blastocysts
FET
Keywords: HRT
PGT-A
Next-generation sequencing (NGS)
Miscarriage rate
single embryo transfer (SET)
EmbryoGlue
BMI
Embryo quality
Hyaluronan-enriched medium
Transfer medium
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 783
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be stratified according to the in-house embryo prognosis classification. Our internal data shows top quality embryos have 65% ongoing pregnancy rate and good quality embryos have 55% ongoing pregnancy rate. We assume a 20% relative increase over the baseline with the intervention which corresponds to 78% and 66% ongoing pregnancy rates for top and good quality euploid embryos, respectively. Total sample size requires in each group corresponds to 295 and 488 transfers of top and good quality embryos for a total of 783. Two interim analyses are 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.
Primary purpose: TREATMENT

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 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).

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.

Primary outcomes:
measure: Live birth rate (LBR)
timeFrame: 41 weeks
Secondary outcomes:
measure: human chorionic gonadotropin (hCG) positiveness
timeFrame: 10-12 days after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 6 weeks
measure: Clinical miscarriage rate
timeFrame: 24 weeks
measure: Ongoing pregnancy rate after 12 weeks
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics LLC
Study officials:
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