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Comparison of Alternative Embryo Culture Systems

B

Bruce Shapiro M.D.

Status

Withdrawn

Conditions

Infertility

Treatments

Other: Enclosed embryo culture
Other: Conventional embryo culture

Study type

Interventional

Funder types

Industry

Identifiers

NCT02028897
SAIRB-13-0040

Details and patient eligibility

About

This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.

Full description

Qualifying and consenting IVF patients will have approximately half of their developing embryos cultured in droplets covered with oil. The other approximate half of their embryos will be cultured in small enclosed containers. Embryo assignments will be at random. Regardless of culture system, all embryos will be cultured from the bipronuclear stage to the blastocyst stage in the same (Global) media, without the usual refreshing of media on day 3.

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Female age 18 to 40, seeking IVF treatment
  • Ability to understand English (to obtain informed consent)
  • Use of an oocyte donor, sperm donor, gestational carrier, and/or genetic testing (with blastocyst biopsy only) are allowed.

Exclusion criteria

  • Diminished ovarian reserve as evidenced by either elevated cycle day 3 follicle stimulating hormone (FSH) level (≥10 IU/L) or low antral follicle count (<8 antral follicles)
  • Fewer than five (5) bipronuclear oocytes
  • Day 3 embryo biopsy for any reason
  • No minors may enroll

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Conventional embryo culture
Active Comparator group
Description:
Conventional embryo culture in dishes, in droplets under oil.
Treatment:
Other: Conventional embryo culture
Alternative embryo culture
Experimental group
Description:
Embryo culture in system using small enclosed containers
Treatment:
Other: Enclosed embryo culture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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