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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01689428

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

Infertility, Miscarriage

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

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