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

NCT01689428 | Unknown

• 2 other identifiers: EG48Asept12EG1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Infertility; Miscarriage

Keywords

IVF; Embryo culture; Ongoing Pregnancy rate; Ongoing Implantation rate; Miscarriage

Outcome Measures

Primary Outcomes (1)

• Ongoing Pregnancy Rate after 12 weeks of gestation

  12 weeks after conception

Secondary Outcomes (1)

• Ongoing Implantation Rate after 12 weeks of gestation

  12 weeks after conception

Study Arms (2)

IVF treatment EmbryoGen

Embryo culture in EmbryoGen medium

IVF treatment ISM1

Embryo culture in ISM1 medium

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \- At least one (maximum 3) miscarriage and/or biochemical pregnancy after ART treatment

You may not qualify if:

• Frozen spermatozoa
• Frozen oocytes
• women with PCO and PCOS
• women with more than 4 ART treatments

Sponsors & Collaborators

• Biogenesi: lead

Study Sites (1)

Biogenesi Reproductive Medicine Centre

Monza, MB, 20900, Italy

Location

Related Publications (1)

• 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.

  PMID: 20129825 BACKGROUND

MeSH Terms

Conditions

Infertility; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Mariabeatrice Dal Canto, PhD

  Biogenesi Reproductive medicine Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 21, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

IT (1)