InfertilityNCT03332680
EmbryoGlue as an Embryo Transfer Medium
A study testing EmbryoGlue® (laboratory culture medium) in people with Infertility, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility
- What is being tested?
- EmbryoGlue® (laboratory culture medium)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2017to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Couples having embryo transfer for fertility treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Assessing the Effectiveness of EmbryoGlue® as an Embryo Transfer Medium in IVF Treatment Cycles
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
- Being tested
- EmbryoGlue® (laboratory culture medium), Standard control medium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryoGlue® (laboratory culture medium)Biological
Also called EmbryoGlue
Embryos placed in this medium prior to transfer
Standard control mediumBiological
Embryos placed in this medium prior to transfer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Standard control medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate
Measured: outcome data up to 9 months after intervention
Secondary outcomes (3)
Implantation rate
Measured: outcome data up to 9 months after intervention
Clinical pregnancy rates,
Measured: outcome data up to 9 months after intervention
Adverse IVF events.
Measured: outcome data up to 9 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start16 Jun 2017
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a positive control study with a single site two arm parallel design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Fertility Limited, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332680
- Sponsor's protocol ID
- NDOG-17/NW/0272
- Status last verified
- Nov 2018
- First submitted
- 17 May 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Assessing the Effectiveness of EmbryoGlue® as an Embryo Transfer Medium in IVF Treatment Cycles
- ClinicalTrials.gov ID
- NCT03332680
- Acronym / sponsor ID
- NDOG-17/NW/0272
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford Fertility Limited, United Kingdom
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a positive control study with a single site two arm parallel design
| Arm | Type | Receives |
|---|---|---|
| EmbryoGlue® (laboratory culture medium) | Experimental | Biological: 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 | Active comparator | Biological: Standard control mediumlaboratory culture medium In standard procedure embryos are placed in a media prior to transfer into uterus via embryo transfer procedure to facilitate IVF. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Couples having embryo transfer for fertility treatment
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbryoGlue® (laboratory culture medium)Also: EmbryoGlueEmbryos placed in this medium prior to transfer | Biological | EmbryoGlue® (laboratory culture medium) |
| Standard control mediumEmbryos placed in this medium prior to transfer | Biological | Standard control medium |
Primary outcome
Live Birth Rate
Time frame: outcome data up to 9 months after intervention
3 secondary outcomes
Implantation rate
Time frame: outcome data up to 9 months after intervention
Clinical pregnancy rates,
Time frame: outcome data up to 9 months after intervention
Adverse IVF events.
Time frame: outcome data up to 9 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmbryoGlue® (laboratory culture medium) in people with Infertility, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth Rate (time frame: outcome data up to 9 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018; AzTrials last refreshed its copy on 2 Nov 2026.