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

This study is currently recruiting participants.
Verified July 2011 by Sykehuset Telemark
Sponsor:
Collaborators:
Cellcura AS
Vekst i Grenland
Innovation Norway
Information provided by:
Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00541892
First received: October 9, 2007
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
In Vitro Fertilization
Infertility
 Other: Medium with no human serum albumine added
Other: Conventional medium
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sibling Oocyte Study of Medium for IVF/ICSI With no Human Serum Albumine

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • Fertilization [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Cleavage [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Embryo score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Embryos used [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Medium with no human serum albumine added
 Other: Medium with no human serum albumine added
See above
Active Comparator: 2
Conventional medium
 Other: Conventional medium
See above

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541892

Contacts
Contact: Jarl Kahn, Dr. med. +47 35005820 Jarl.Arne.Kahn@sthf.no

Locations
Norway
Fertilitetsklinikken Sør Recruiting
Porsgrunn, Telemark, Norway, 3901
Contact: Jarl Kahn, Dr. Med     +47 35005820     Jarl.Arne.Kahn@sthf.no    
Sponsors and Collaborators
Sykehuset Telemark
Cellcura AS
Vekst i Grenland
Innovation Norway
Investigators
Study Director: Jarl Kahn, Dr. Med Fertilitetsklinikken Sør
  More Information

No publications provided

Responsible Party: Jarl Kahn, Fertilitetsklinikken Sør
ClinicalTrials.gov Identifier: NCT00541892     History of Changes
Other Study ID Numbers: s-05249, 14231(NSD)
Study First Received: October 9, 2007
Last Updated: July 20, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Sykehuset Telemark:
Cell Culture Techniques

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013