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

B

Biogenesi

Status

Unknown

Conditions

Infertility
Implantation Failure

Study type

Observational

Funder types

Other

Identifiers

NCT01689454
EG48BSept12
EG2 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Volunteers

No 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

Trial design

100 participants in 2 patient groups

IVF treatment ISM1
Description:
Embryo culture in ISM1 medium
IVF treatment EG
Description:
Embryo culture in EmbryoGen medium

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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