InfertilityNCT01689428
Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases
An observational study of Infertility and Miscarriage, run by Biogenesi at 1 site in Italy.
Trial summary
Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss. Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical pregnancy will be included in the study. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Miscarriage
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infertile couple with an indication for standard IVF or intracytoplasmic sperm injection. Moreover all couples had at least a previous miscarriage and/or biochemical pregnancy experience after ART treatment.
Who may be able to join
- At least one (maximum 3) miscarriage and/or biochemical pregnancy after ART treatment
Who cannot join
- Frozen spermatozoa
- Frozen oocytes
- women with PCO and PCOS
- women with more than 4 ART treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trail to Assess the Efficacy of EmbryoGen Culture Medium to Improve Ongoing Pregnancy and Implantation Rates in IVF Treatments of Patients With a Previous History of Pregnancy Loss
Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss.
Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical pregnancy will be included in the study.
Read more
Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions.
Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups.
The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As secondary outcome the investigators will assume a 5% of increment in ongoing implantation rate after 12 weeks in the group with EmbryoGen medium.
- Conditions
- Infertility, Miscarriage
- Keywords
- IVF, Embryo culture, Ongoing Pregnancy rate, Ongoing Implantation rate, Miscarriage
- Medical subject headings
- Infertility, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVF treatment EmbryoGen | Embryo culture in EmbryoGen medium | |
| IVF treatment ISM1 | Embryo culture in ISM1 medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy Rate after 12 weeks of gestation
Measured: 12 weeks after conception
Secondary outcomes (1)
Ongoing Implantation Rate after 12 weeks of gestation
Measured: 12 weeks after conception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2013 (estimated)
- Study completionSep 2013 (estimated)
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 InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogenesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariabeatrice Dal Canto, PhD, Principal investigator, Biogenesi Reproductive medicine Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689428
- Sponsor's protocol ID
- EG48Asept12
- Other IDs
- EG1
- Status last verified
- Sep 2012
- First submitted
- 10 Sep 2012
- Last updated
- 21 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Agerholm I, Loft A, Hald F, Lemmen JG, Munding B, Sorensen PD, Ziebe S. Culture of human oocytes with granulocyte-macrophage colony-stimulating factor has no effect on embryonic chromosomal constitution. Reprod Biomed Online. 2010 Apr;20(4):477-84. doi: 10.1016/j.rbmo.2009.12.026. Epub 2009 Dec 28.
PubMed 20129825
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trail to Assess the Efficacy of EmbryoGen Culture Medium to Improve Ongoing Pregnancy and Implantation Rates in IVF Treatments of Patients With a Previous History of Pregnancy Loss
- ClinicalTrials.gov ID
- NCT01689428
- Acronym / sponsor ID
- EG48Asept12
- Conditions
- Infertility, Miscarriage
- Keywords
- IVF, Embryo culture, Ongoing Pregnancy rate, Ongoing Implantation rate, Miscarriage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BiogenesiUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 21 Sep 2012 (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.
Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss.
Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical pregnancy will be included in the study.
Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions.
Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups.
The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As secondary outcome the investigators will assume a 5% of increment in ongoing implantation rate after 12 weeks in the group with EmbryoGen medium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF treatment EmbryoGen | – | –Embryo culture in EmbryoGen medium |
| IVF treatment ISM1 | – | –Embryo culture in ISM1 medium |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infertile couple with an indication for standard IVF or intracytoplasmic sperm injection. Moreover all couples had at least a previous miscarriage and/or biochemical pregnancy experience after ART treatment.
Key inclusion criteria (1 listed)
- At least one (maximum 3) miscarriage and/or biochemical pregnancy after ART treatment
Key exclusion criteria (4 listed)
- Frozen spermatozoa
- Frozen oocytes
- women with PCO and PCOS
- women with more than 4 ART treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ongoing Pregnancy Rate after 12 weeks of gestation
Time frame: 12 weeks after conception
1 secondary outcome
Ongoing Implantation Rate after 12 weeks of gestation
Time frame: 12 weeks after conception
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2012.
- Background: PubMed 20129825Agerholm I, Loft A, Hald F, Lemmen JG, Munding B, Sorensen PD, Ziebe S. Culture of human oocytes with granulocyte-macrophage colony-stimulating factor has no effect on embryonic chromosomal constitution. Reprod Biomed Online. 2010 Apr;20(4):477-84. doi: 10.1016/j.rbmo.2009.12.026. Epub 2009 Dec 28.
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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.
Mariabeatrice Dal Canto, PhD principal investigator
Biogenesi Reproductive medicine Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Miscarriage, run by Biogenesi at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 21 Sep 2012. 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 Italy. 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?
Ongoing Pregnancy Rate after 12 weeks of gestation (time frame: 12 weeks after conception). 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 NCT01689428, 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 21 Sep 2012.