Hyaluronan-enriched Medium and Euploid Blastocyst Transfers (GluePloid)

January 30, 2024 updated by: Daniela Nogueira, ART Fertility Clinics LLC

Impact of Hyaluronan-enriched Medium on Pregnancy Outcomes Following Euploid Blastocyst Transfers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

783

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Blastocysts exposed to normal media (NEG)
Blastocysts exposed to routine-in use medium No intervention
Active Comparator: Blastocysts exposed to EmbryoGlue (EG)
Blastocysts exposed to EmbryoGlue
Drug: EmbryoGlue Medium
Embryos will be exposed to hyaluronic-enriched media (EmbryoGlue) before and during embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate (LBR)
Time Frame: 41 weeks
Defined as the delivery if a live infant born after 24 completed weeks of gestation
41 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART FERTILITY CLINICS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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