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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00541892
Other study ID # s-05249
Secondary ID 14231(NSD)
Status Withdrawn
Phase Phase 2
First received October 9, 2007
Last updated May 19, 2015
Start date September 2007
Est. completion date January 2014

Study information

Verified date May 2015
Source Sykehuset Telemark
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.


Description:

Cells attained in IVF/ICSI procedures are kept in a medium that nurture the cells. Until now all such media have contained human serum albumine. The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria:

- Couples seeking IVF/ICSI.

- Female under 38 years of age.

- No more than two previous IVF/ICSI treatments without pregnancy.

- Regular menstruation periods.

- No endocrine disease that requires treatment in the female.

- BMI below 30 in the female.

- At least 8 mature follicles upon monitoring or 6 MII oocytes upon ICSI.

- Written informed consent.

Exclusion Criteria:

- Low responders to FSH.

- Females in danger of developing OHSS.

- Sperm sample below ICSI-quality.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Medium with no human serum albumine added
See above
Conventional medium
See above

Locations

Country Name City State
Norway Fertilitetsklinikken Sør Porsgrunn Telemark

Sponsors (4)

Lead Sponsor Collaborator
Sykehuset Telemark Cellcura AS, Innovation Norway, Vekst i Grenland

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fertilization 24 hours No
Primary Cleavage 48 hours No
Primary Embryo score 48 hours No
Primary Embryos used 48 hours No
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