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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02066584
Other study ID # 0011-14HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 16, 2014
Last updated February 18, 2014
Start date April 2014
Est. completion date April 2016

Study information

Verified date February 2014
Source Hillel Yaffe Medical Center
Contact Medeia Michaeli, PhD
Phone 972-50-6246885
Email medeia_michaeli@yahoo.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The importance of glucose in culture media on fertilization and embryo development is still controversial. Although it has been reported that glucose is essential for fertilization process and biosynthesis of membrane lipid and nucleic acids, comparatively high levels of glucose in culture media may cause developmental arrest of cleavage stage embryos. The aim of this retrospective study is to examine whether exposure of sibling oocytes to different concentrations of glucose in culture media has any further effect on IVF outcome.


Description:

This retrospective study will include data from either standard IVF or Intracytoplasmic Sperm Injection (ICSI) cycles, in which sibling oocytes were equally divided and incubated separately in one of the following pairs of culture media:

1. Universal IVF medium vs. ISM1 medium ( Origio, Medi-Cult)

2. P1 medium vs. ECM medium (Irvine).

Fertilization rate,as well as embryo cleavage rate and morphology will be evaluated.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 42 Years
Eligibility Inclusion Criteria:

- Sibling oocytes from cycles where at least 4 oocytes were retrieved

Exclusion Criteria:

- Less than 4 oocytes retrieved

- Partner has undergone testicular sperm extraction (TESE)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Sibling oocyte incubation


Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fertilization Rate Fertilization rates will be retrospectively compared according to culture media in which sibling oocytes were incubated 2 years No
Secondary Embryo Quality Embryo quality and developmental rate will be retrospectively compared according to culture media in which sibling oocytes were incubated 2 years No
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