EmbryoGlue as an Embryo Transfer Medium

NCT03332680 | Unknown

• 1 other identifier: NDOG-17/NW/0272
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Live Birth Rate

  outcome data up to 9 months after intervention

Secondary Outcomes (3)

• 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

Study Arms (2)

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

EmbryoGlue® (laboratory culture medium) BIOLOGICAL

Embryos placed in this medium prior to transfer

Also known as: EmbryoGlue

EmbryoGlue® (laboratory culture medium)

Standard control medium BIOLOGICAL

Embryos placed in this medium prior to transfer

Standard control medium

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Couples having embryo transfer for fertility treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Oxford Fertility Limited, United Kingdom: collaborator

Study Sites (1)

Oxford Fertility

Oxford, OX4 2HW, United Kingdom

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a positive control study with a single site two arm parallel design

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: November 6, 2017
• Study Start: June 16, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

GB (1)