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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01689428
• Other study ID #: EG48Asept12
• Secondary ID: EG1
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: September 10, 2012
• Last updated: September 17, 2012
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2012
• Source: Biogenesi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Infertility
• Miscarriage

Locations

Country	Name	City	State
Italy	Biogenesi Reproductive Medicine Centre	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
Biogenesi

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Agerholm I, Loft A, Hald F, Lemmen JG, Munding B, Sørensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Pregnancy Rate after 12 weeks of gestation		12 weeks after conception	No
Secondary	Ongoing Implantation Rate after 12 weeks of gestation		12 weeks after conception	No