Hyaluronan-enriched Medium and Euploid Blastocyst Transfers

Not Applicable

Recruiting

• Conditions: Clinical Pregnancy Rate; Live Birth Rate; Blastocysts; FET; Infertility; Implantation Rate
• Interventions: Drug: EmbryoGlue Medium

• Registration Number: NCT06165367
• Lead Sponsor: ART Fertility Clinics LLC

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).

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-11
• Study Start: 2024-01-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 783

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blastocysts exposed to EmbryoGlue (EG)	EmbryoGlue Medium	Blastocysts exposed to EmbryoGlue

Primary Outcome Measures

Name	Time	Method
Live birth rate (LBR)	41 weeks	Defined as the delivery if a live infant born after 24 completed weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6 weeks	ultrasonographic sac visible at 5 gestational weeks
human chorionic gonadotropin (hCG) positiveness	10-12 days after embryo transfer	hCG pregnancy test checks human chorionic gonadotropin (HCG) levels in the blood.
Clinical miscarriage rate	24 weeks	spontaneous loss of a clinical pregnancy before 24 weeks of gestation
Ongoing pregnancy rate after 12 weeks	13 weeks	viable pregnancy with gestational age more than 12 weeks

Trial Locations

Locations (1)

ART Fertility Clinics LLC; 🇦🇪 Abu Dhabi, United Arab Emirates