EmbryoGlue as an Embryo Transfer Medium | NCT03332680

Studies
EmbryoGlue as an Embryo Transfer Medium

NCT03332680

Sponsor

University of Oxford

Status

Unknown status

Last Update Posted

Nov 30, 2018Actual

Enrollment

730Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

EmbryoGlue® (laboratory culture medium)
Standard control medium

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2017Actual

Primary Completion Date

Nov 30, 2019Estimated

Completion Date

Nov 30, 2019Estimated

First Submitted Date

May 17, 2017

First Submission Date that Met QC Criteria

Nov 3, 2017

First Posted Date

Nov 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2018

Last Update Posted Date

Nov 30, 2018Actual

Name	Class
Oxford Fertility Limited, United Kingdom	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

730Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EmbryoGlue® (laboratory culture medium)	Experimental	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)
Standard control medium	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EmbryoGlue® (laboratory culture medium)	Biological	Embryos placed in this medium prior to transfer	EmbryoGlue® (laboratory culture medium)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oxford Fertility		Oxford		OX4 2HW	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

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).

Who Masked

ParticipantInvestigatorOutcomes Assessor