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Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases

NCT01689428 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2012-09-21

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Biogenesi

    lead OTHER

Principal Investigators

  • Mariabeatrice Dal Canto, PhD · Biogenesi Reproductive medicine Centre

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-06-30
Completion
2013-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01689428 on ClinicalTrials.gov