Comparison of Alternative Embryo Culture Systems

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02028897

Enrollment

Registered

2014-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2015-01-08

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

Conditions

Infertility

Keywords

In vitro fertilization, IVF, Embryo culture, Blastocyst transfer

Brief summary

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.

Detailed 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.

Interventions

OTHERConventional embryo culture

OTHEREnclosed embryo culture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Blastulation rate	5 days (sixth day of embryo development)	Proportion of cultured embryos that form blastocysts.

Secondary

Measure	Time frame	Description
Blastocyst morphology	5 days (sixth day of development)	Inner cell mass size, number of trophectoderm cells, blastocyst diameter
IVF outcome	7 weeks post-transfer	The result of the IVF cycle as no pregnancy, early pregnancy loss, or ongoing pregnancy at 10 weeks gestation (about 7 weeks post-transfer).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026