Comparison of Alternative Embryo Culture Systems

Infertility Clinical Trial

Official title:

Comparison of Alternative Embryo Culture Systems

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02028897
• Other study ID #: SAIRB-13-0040
• Status: Withdrawn
• Phase: N/A
• First received: January 6, 2014
• Last updated: January 7, 2015

Study information

• Verified date: January 2015
• Source: Fertility Center of Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Conventional embryo culture

• Enclosed embryo culture

Locations

Country	Name	City	State
United States	Fertility Center of Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Bruce Shapiro M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastulation rate	Proportion of cultured embryos that form blastocysts.	5 days (sixth day of embryo development)	No
Secondary	Blastocyst morphology	Inner cell mass size, number of trophectoderm cells, blastocyst diameter	5 days (sixth day of development)	No
Secondary	IVF outcome	The result of the IVF cycle as no pregnancy, early pregnancy loss, or ongoing pregnancy at 10 weeks gestation (about 7 weeks post-transfer).	7 weeks post-transfer	No