Comparison of Alternative Embryo Culture Systems

Not Applicable

Withdrawn

• Conditions: Infertility
• Interventions: Other: Conventional embryo culture; Other: Enclosed embryo culture

• Registration Number: NCT02028897
• Lead Sponsor: Bruce Shapiro M.D.

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.

Study Timeline

• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional embryo culture	Conventional embryo culture	Conventional embryo culture in dishes, in droplets under oil.
Alternative embryo culture	Enclosed embryo culture	Embryo culture in system using small enclosed containers

Primary Outcome Measures

Name	Time	Method
Blastulation rate	5 days (sixth day of embryo development)	Proportion of cultured embryos that form blastocysts.

Secondary Outcome Measures

Name	Time	Method
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).
Blastocyst morphology	5 days (sixth day of development)	Inner cell mass size, number of trophectoderm cells, blastocyst diameter

Trial Locations

Locations (1)

Fertility Center of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States