Infertility
Conditions
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.
Interventions
BIOLOGICALEmbryoGlue® (laboratory culture medium)
Embryos placed in this medium prior to transfer
BIOLOGICALStandard control medium
Embryos placed in this medium prior to transfer
Sponsors
Oxford Fertility Limited, United Kingdom
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes 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).
Intervention model description
This study is a positive control study with a single site two arm parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live Birth Rate | outcome data up to 9 months after intervention |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed