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EmbryoGlue as an Embryo Transfer Medium

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EmbryoGlue® (laboratory culture medium)
Standard control medium
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oxford Fertility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EmbryoGlue® (laboratory culture medium)

Standard control medium

Arm Description

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.

laboratory culture medium In standard procedure embryos are placed in a media prior to transfer into uterus via embryo transfer procedure to facilitate IVF.

Outcomes

Primary Outcome Measures

Live Birth Rate

Secondary Outcome Measures

Implantation rate
Clinical pregnancy rates,
Adverse IVF events.

Full Information

First Posted
May 17, 2017
Last Updated
November 28, 2018
Sponsor
University of Oxford
Collaborators
Oxford Fertility Limited, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03332680
Brief Title
EmbryoGlue as an Embryo Transfer Medium
Official Title
A Randomised Controlled Trial Assessing the Effectiveness of EmbryoGlue® as an Embryo Transfer Medium in IVF Treatment Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford Fertility Limited, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a positive control study with a single site two arm parallel design
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
In terms of blinding, the physician and/or nurses as well as the patients will be blinded and will not know what arm of the study the participant has been allocated too. The embryologists however will be unblinded (as they provide intervention and will have to be aware).
Allocation
Randomized
Enrollment
730 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EmbryoGlue® (laboratory culture medium)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard control medium
Arm Type
Active Comparator
Arm Description
laboratory culture medium In standard procedure embryos are placed in a media prior to transfer into uterus via embryo transfer procedure to facilitate IVF.
Intervention Type
Biological
Intervention Name(s)
EmbryoGlue® (laboratory culture medium)
Other Intervention Name(s)
EmbryoGlue
Intervention Description
Embryos placed in this medium prior to transfer
Intervention Type
Biological
Intervention Name(s)
Standard control medium
Intervention Description
Embryos placed in this medium prior to transfer
Primary Outcome Measure Information:
Title
Live Birth Rate
Time Frame
outcome data up to 9 months after intervention
Secondary Outcome Measure Information:
Title
Implantation rate
Time Frame
outcome data up to 9 months after intervention
Title
Clinical pregnancy rates,
Time Frame
outcome data up to 9 months after intervention
Title
Adverse IVF events.
Time Frame
outcome data up to 9 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Oxford Fertility
City
Oxford
ZIP/Postal Code
OX4 2HW
Country
United Kingdom

12. IPD Sharing Statement

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EmbryoGlue as an Embryo Transfer Medium

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