Recurrent MiscarriagePhase 4BlastGenNCT02305420
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
A Phase 4 study testing EmbryoGen/ BlastGen media and Standard Cook sequential media in people with Recurrent Miscarriage and Infertility, run by FertilitySA at 1 site in Australia.
Trial summary
EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to this difficult group of patients. Read more about this study
- Who is it for?
- Ages 25 to 41 years, women only
- Conditions the study is for
- Recurrent Miscarriage, Infertility
- What is being tested?
- EmbryoGen/ BlastGen media and Standard Cook sequential media
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2014to 14 Jun 2017
- Phase
- Phase 4
- 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 25 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undertaking an IVF or ICSI cycle
- aged between 25 and 41 years
- 2 or more embryos transferred without a positive pregnancy outcome OR a history of at least 1 previous pregnancy loss, OR
- Poor embryo development (<20% of embryo developing on time at Day 3 or no blastocyst above Grade 2 on Day 5)
Who cannot join
- male partner requiring surgical retrieval of sperm except in cases of previous vasectomy
- the use of another investigational drug within 30 days
- any severe chronic disease that would significantly influence an IVF cycle
- less than 3 follicles>14mm on ultrasound on the day of HCG trigger
Trial locations and contacts
1 site in 1 country.
About this study
EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to this difficult group of patients.
Results showed a highly significant effect of 44% relative improvement in ongoing implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).
We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media improves pregnancy outcomes in women with recurrent implantation failure, recurrent miscarriage and poor embryo development when compared to standard media.
Read the detailed description
A randomised control pilot study will be undertaken for 100 women who have implantation failure (≥ 2 embryo transfers without a pregnancy) or at least 1 previous miscarriage and are having a further IVF cycle.
At oocyte retrieval each couple will be randomised using numbered envelopes containing pre randomised group allocations by a person uninvolved in the trial to:
- BlastGen Group (n=50): culturing their embryos in ORIGIO standard, sequential culture mediums for 3 days (EmbryoGen included) then BlastGen media (GM-CSF containing media) for remaining 2 days or
- Standard Media Group (n=50): culturing their embryos in Cook standard sequential medium for 5 days.
The best single embryo will be transferred on day 5.
The clinical staff and participating couple will be blinded as to whether BlastGen or standard media was used in culture to day 5. Fertility SA embryologists will not be blind as to which study group a couple is in and which media is being used. The embryos will be cultured using the usual methods and lab facilities by Fertility SA's current embryology staff members who will not be blind to the media being used.
Records on the outcome of the oocyte fertilisation, blastocyst development, implantation rate and pregnancy rates will be recorded, as is standard practice. Pregnancy scans will be carried out at 7 and 12 weeks. Live birth outcomes and any congenital anomalies will be recorded.
- Conditions
- Recurrent Miscarriage, Infertility
- Being tested
- EmbryoGen/ BlastGen media, Standard Cook sequential media
- Medical subject headings
- Abortion, Habitual, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryoGen/ BlastGen mediaDevice
Also called GM-CSF containing media
Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)
Standard Cook sequential mediaDevice
Standard Cook IVF media will be used in the control arm
| Study group | Role | What they receive |
|---|---|---|
| EmbryoGen/BlastGen | Experimental | EmbryoGen and BlasGen media containing GM-CSF 2ng/ml will be used in the experimental arm
The intervention is to use EmbryoGen/BlastGen Receives: Device: EmbryoGen/ BlastGen media |
| Control | Active comparator | Standard Cook sequential media Receives: Device: Standard Cook sequential media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Livebirth >20 weeks
Any delivery >20 resulting in a livebirth
Measured: 9 months after closure of trial (18 +9 months)
Secondary outcomes (5)
Congenital Anomaly Rate
number of liveborns with a congenital anomaly
Measured: 9 months after closure of trial (18 +9 months)
Clinical pregnancy rates at 7 and 12 weeks gestation
Fetal Heart Beat seen on Ultrasound scan at 7 and 12 weeks
Measured: 18 months
Number of embryos reaching blastocyst stage
Number of blastocysts per cycle
Measured: 18 months
Day 3 and day 5 embryo scores
grade of day 3 and day 5 embryos
Measured: 18 months
Cryopreservation outcomes
Number of Frozen blastocysts
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised control trial comparing EmbryoGen/ BlastGen media use with standard media in IVF
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- FertilitySA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Adelaide
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305420
- Sponsor's protocol ID
- 8114
- Acronym
- BlastGen
- Status last verified
- Feb 2018
- First submitted
- 27 Nov 2014
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rose RD, Barry MF, Dunstan EV, Yuen SM, Cameron LP, Knight EJ, Norman RJ, Hull ML. The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor. Reprod Biomed Online. 2020 May;40(5):645-652. doi: 10.1016/j.rbmo.2020.01.011. Epub 2020 Jan 23.
PubMed 32220517
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
- ClinicalTrials.gov ID
- NCT02305420
- Acronym / sponsor ID
- BlastGen / 8114
- Conditions
- Recurrent Miscarriage, Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- FertilitySAIndustry (pharma, biotech, devices)
- Collaborators
- University of Adelaide
- Study start
- Nov 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 2 Dec 2014 (estimated)
- 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.
EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to this difficult group of patients.
Results showed a highly significant effect of 44% relative improvement in ongoing implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).
We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media improves pregnancy outcomes in women with recurrent implantation failure, recurrent miscarriage and poor embryo development when compared to standard media.
Detailed description
A randomised control pilot study will be undertaken for 100 women who have implantation failure (≥ 2 embryo transfers without a pregnancy) or at least 1 previous miscarriage and are having a further IVF cycle.
At oocyte retrieval each couple will be randomised using numbered envelopes containing pre randomised group allocations by a person uninvolved in the trial to:
- BlastGen Group (n=50): culturing their embryos in ORIGIO standard, sequential culture mediums for 3 days (EmbryoGen included) then BlastGen media (GM-CSF containing media) for remaining 2 days or
- Standard Media Group (n=50): culturing their embryos in Cook standard sequential medium for 5 days.
The best single embryo will be transferred on day 5.
The clinical staff and participating couple will be blinded as to whether BlastGen or standard media was used in culture to day 5. Fertility SA embryologists will not be blind as to which study group a couple is in and which media is being used. The embryos will be cultured using the usual methods and lab facilities by Fertility SA's current embryology staff members who will not be blind to the media being used.
Records on the outcome of the oocyte fertilisation, blastocyst development, implantation rate and pregnancy rates will be recorded, as is standard practice. Pregnancy scans will be carried out at 7 and 12 weeks. Live birth outcomes and any congenital anomalies will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised control trial comparing EmbryoGen/ BlastGen media use with standard media in IVF
| Arm | Type | Receives |
|---|---|---|
| EmbryoGen/BlastGen | Experimental | Device: EmbryoGen/ BlastGen mediaEmbryoGen and BlasGen media containing GM-CSF 2ng/ml will be used in the experimental arm The intervention is to use EmbryoGen/BlastGen |
| Control | Active comparator | Device: Standard Cook sequential mediaStandard Cook sequential media |
Who may qualify
- Ages
- 25 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women undertaking an IVF or ICSI cycle
Key exclusion criteria (4 listed)
- male partner requiring surgical retrieval of sperm except in cases of previous vasectomy
- the use of another investigational drug within 30 days
- any severe chronic disease that would significantly influence an IVF cycle
- less than 3 follicles>14mm on ultrasound on the day of HCG trigger
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 |
|---|---|---|
| EmbryoGen/ BlastGen mediaAlso: GM-CSF containing mediaEmbryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media) | Device | EmbryoGen/BlastGen |
| Standard Cook sequential mediaStandard Cook IVF media will be used in the control arm | Device | Control |
Primary outcome
Livebirth >20 weeks
Time frame: 9 months after closure of trial (18 +9 months)
Any delivery >20 resulting in a livebirth
5 secondary outcomes
Congenital Anomaly Rate
Time frame: 9 months after closure of trial (18 +9 months)
Clinical pregnancy rates at 7 and 12 weeks gestation
Time frame: 18 months
Number of embryos reaching blastocyst stage
Time frame: 18 months
Day 3 and day 5 embryo scores
Time frame: 18 months
Cryopreservation outcomes
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Derived from this study: PubMed 32220517Rose RD, Barry MF, Dunstan EV, Yuen SM, Cameron LP, Knight EJ, Norman RJ, Hull ML. The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor. Reprod Biomed Online. 2020 May;40(5):645-652. doi: 10.1016/j.rbmo.2020.01.011. Epub 2020 Jan 23.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing EmbryoGen/ BlastGen media and Standard Cook sequential media in people with Recurrent Miscarriage and Infertility, run by FertilitySA at 1 site in Australia.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Feb 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Livebirth >20 weeks (time frame: 9 months after closure of trial (18 +9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305420, which also lists 1 linked publication.
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 19 Feb 2018.