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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Sykehuset Telemark.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014