EmbryoGlue as an Embryo Transfer Medium

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03332680
• Other study ID #: NDOG-17/NW/0272
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 16, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: November 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 730
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Biological:
• EmbryoGlue® (laboratory culture medium)
Embryos placed in this medium prior to transfer
• Standard control medium
Embryos placed in this medium prior to transfer

Locations

Country	Name	City	State
United Kingdom	Oxford Fertility	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford Fertility Limited, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live Birth Rate		outcome data up to 9 months after intervention
Secondary	Implantation rate		outcome data up to 9 months after intervention
Secondary	Clinical pregnancy rates,		outcome data up to 9 months after intervention
Secondary	Adverse IVF events.		outcome data up to 9 months after intervention