Clinical trial NCT01689454: ISM1 Versus EmbrioGen Media for Embryo Culture With Previous Failure Implantation in ART Treatments
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 Implantation Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Implantation Failure
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 previous implantation failures after ART treatment (minimun 2 maximun 4 embryo replacements).

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 implantation failure 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.


Eligibility criteria: Inclusion Criteria:

* women experiencing at least two (maximum 4) failures of implantation after ART treatments (with elective embryo transfer)

Exclusion Criteria:

* Frozen spermatozoa
* Frozen oocytes
* women PCO and PCOS
* women with previous pregnancy, miscarriage or biochemical pregnancy

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.