EmbryoGlue as an Embryo Transfer Medium

Not Applicable

• Conditions: Infertility
• Interventions: Biological: EmbryoGlue® (laboratory culture medium); Biological: Standard control medium

• Registration Number: NCT03332680
• Lead Sponsor: University of Oxford

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-17
• Study Start: 2017-06-16
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-06
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

• Couples having embryo transfer for fertility treatment

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EmbryoGlue® (laboratory culture medium)	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.
Standard control medium	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.

Primary Outcome Measures

Name	Time	Method
Live Birth Rate	outcome data up to 9 months after intervention

Secondary Outcome Measures

Name	Time	Method
Implantation rate	outcome data up to 9 months after intervention
Clinical pregnancy rates,	outcome data up to 9 months after intervention
Adverse IVF events.	outcome data up to 9 months after intervention

Trial Locations

Locations (1)

Oxford Fertility; 🇬🇧 Oxford, United Kingdom