EmbryoGlue as an Embryo Transfer Medium

Study Overview
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Biological: EmbryoGlue® (laboratory culture medium)
* Biological: Standard control medium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a positive control study with a single site two arm parallel design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EmbryoGlue® (laboratory culture medium)<br>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)<br>* Embryos placed in this medium prior to transfer<br>* Other names: EmbryoGlue;|
| Active Comparator: Standard control medium<br>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<br>* Embryos placed in this medium prior to transfer<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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. |  | outcome data up to 9 months after intervention |