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

B

Biogenesi

Status

Unknown

Conditions

Infertility
Miscarriage

Study type

Observational

Funder types

Other

Identifiers

NCT01689428
EG1 (Other Identifier)
EG48Asept12

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 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.

Enrollment

100 estimated patients

Sex

Female

Volunteers

No 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

Trial design

100 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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