Clinical trial NCT01689428: Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Miscarriage
Keywords: IVF
Embryo culture
Ongoing Pregnancy rate
Ongoing Implantation rate
Miscarriage
Lead sponsor: Biogenesi
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ongoing Pregnancy Rate after 12 weeks of gestation
timeFrame: 12 weeks after conception
Secondary outcomes:
measure: Ongoing Implantation Rate after 12 weeks of gestation
timeFrame: 12 weeks after conception
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Biogenesi Reproductive Medicine Centre
state: MB
Study officials:
affiliation: Biogenesi Reproductive medicine Centre
name: Mariabeatrice Dal Canto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.