ISM1 Versus EmbrioGen Media for Embryo Culture With Previous Failure Implantation in ART Treatments

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01689454

Enrollment

100

Registered

2012-09-21

Start date

2012-09-30

Completion date

2013-09-30

Last updated

2012-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantation Failure, Infertility

Keywords

IVF, embryo culture, Ongoing pregnancy rate, Ongoing implantation rate, Miscarriage

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Ongoing Pregnancy Rate after 12 weeks of gestation	12 weeks after conception

Secondary

Measure	Time frame
Ongoing Implantation Rate after 12 weeks of gestation	12 weeks after conception

Countries

Italy

Outcome results