EmbryoGlue as an Embryo Transfer Medium

November 28, 2018 updated by: University of Oxford

A Randomised Controlled Trial Assessing the Effectiveness of EmbryoGlue® as an Embryo Transfer Medium in IVF Treatment Cycles

In Vitro Fertilisation (IVF) is an increasingly common treatment for infertility. Clinics which offer IVF are continuously trying to improve their success rates, measured by the numbers of IVF cycles which result in the birth of a live baby.

One factor which is thought to have contributed to the success of IVF is the improvements in the embryo culture media, that is, the fluid in which the embryo resides in the laboratory before being replaced into a woman's womb. This trial seeks to identify if IVF cycles in which a particular culture media called EmbryoGlue is used have better results when compared to IVF cycles in which a conventional embryo transfer media is used.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

730

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 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

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Couples having embryo transfer for fertility treatment

Exclusion Criteria:

  • Cycles in which elective freezing of all embryos is clinically indicated (e.g. severe risk of OHSS, biopsy patients)
  • Use of donor gametes
  • Having endometrial scratch technique this cycle
  • Concurrent participation in clinical trial(s)
  • Previously randomised to this study
  • Planned self-fund of EmbryoGlue as transfer media

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EmbryoGlue® (laboratory culture medium)

laboratory culture medium

laboratory embryo culture medium, embryos are placed in this media prior to transfer into uterus via embryo transfer procedure to facilitate IVF. EmbryoGlue contains Hyaluronic acid.
Biological: EmbryoGlue® (laboratory culture medium)
Embryos placed in this medium prior to transfer
Other Names:
  • EmbryoGlue
Active Comparator: Standard control medium

laboratory culture medium

In standard procedure embryos are placed in a media prior to transfer into uterus via embryo transfer procedure to facilitate IVF.
Biological: Standard control medium
Embryos placed in this medium prior to transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live Birth Rate
Time Frame: outcome data up to 9 months after intervention
outcome data up to 9 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Implantation rate
Time Frame: outcome data up to 9 months after intervention
outcome data up to 9 months after intervention
Clinical pregnancy rates,
Time Frame: outcome data up to 9 months after intervention
outcome data up to 9 months after intervention
Adverse IVF events.
Time Frame: outcome data up to 9 months after intervention
outcome data up to 9 months after intervention

Collaborators and Investigators

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

Sponsor

University of Oxford

Collaborators

Oxford Fertility Limited, United Kingdom

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)

June 16, 2017

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

November 30, 2019

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDOG-17/NW/0272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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