Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases
NCT ID: NCT01689428
Last Updated: 2012-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2012-09-30
2013-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IVF treatment EmbryoGen
Embryo culture in EmbryoGen medium
No interventions assigned to this group
IVF treatment ISM1
Embryo culture in ISM1 medium
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Frozen oocytes
* women with PCO and PCOS
* women with more than 4 ART treatments
FEMALE
No
Sponsors
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Biogenesi
OTHER
Responsible Party
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Principal Investigators
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Mariabeatrice Dal Canto, PhD
Role: PRINCIPAL_INVESTIGATOR
Biogenesi Reproductive medicine Centre
Locations
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Biogenesi Reproductive Medicine Centre
Monza, MB, Italy
Countries
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References
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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.
Other Identifiers
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EG1
Identifier Type: OTHER
Identifier Source: secondary_id
EG48Asept12
Identifier Type: -
Identifier Source: org_study_id
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