Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine

Infertility Clinical Trial

Official title:

Sibling Oocyte Study of Medium for IVF/ICSI With no Human Serum Albumine

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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

• In Vitro Fertilization
• Infertility

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