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EmbryoGlue as an Embryo Transfer Medium

NCT ID: NCT03332680

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

730 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-16

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a positive control study with a single site two arm parallel design
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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).

Study Groups

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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.

Group Type EXPERIMENTAL

EmbryoGlue® (laboratory culture medium)

Intervention Type BIOLOGICAL

Embryos placed in this medium prior to transfer

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.

Group Type ACTIVE_COMPARATOR

Standard control medium

Intervention Type BIOLOGICAL

Embryos placed in this medium prior to transfer

Interventions

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EmbryoGlue® (laboratory culture medium)

Embryos placed in this medium prior to transfer

Intervention Type BIOLOGICAL

Standard control medium

Embryos placed in this medium prior to transfer

Intervention Type BIOLOGICAL

Other Intervention Names

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EmbryoGlue

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford Fertility Limited, United Kingdom

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oxford Fertility

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NDOG-17/NW/0272

Identifier Type: -

Identifier Source: org_study_id