- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01689428
Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
MB
-
Monza, MB, Italy, 20900
- Biogenesi Reproductive Medicine Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- At least one (maximum 3) miscarriage and/or biochemical pregnancy after ART treatment
Exclusion Criteria:
- Frozen spermatozoa
- Frozen oocytes
- women with PCO and PCOS
- women with more than 4 ART treatments
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
IVF treatment EmbryoGen
Embryo culture in EmbryoGen medium
|
IVF treatment ISM1
Embryo culture in ISM1 medium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ongoing Pregnancy Rate after 12 weeks of gestation
Time Frame: 12 weeks after conception
|
12 weeks after conception
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ongoing Implantation Rate after 12 weeks of gestation
Time Frame: 12 weeks after conception
|
12 weeks after conception
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mariabeatrice Dal Canto, PhD, Biogenesi Reproductive Medicine Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EG48Asept12
- EG1 (Other Identifier: Biogenesi Reproductive Medicine Centre)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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