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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This study has been withdrawn prior to enrollment.
(senior coworker retired)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00541892
First Posted: October 10, 2007
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cellcura AS
Vekst i Grenland
Innovation Norway
Information provided by (Responsible Party):
Hans Ivar Hanevik, Sykehuset Telemark
  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: None (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 Hans Ivar Hanevik, Sykehuset Telemark:

Primary Outcome Measures:
  • Fertilization [ Time Frame: 24 hours ]
  • Cleavage [ Time Frame: 48 hours ]
  • Embryo score [ Time Frame: 48 hours ]
  • Embryos used [ Time Frame: 48 hours ]

Enrollment: 0
Study Start Date: September 2007
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541892


Locations
Norway
Fertilitetsklinikken Sør
Porsgrunn, Telemark, Norway, 3901
Sponsors and Collaborators
Sykehuset Telemark
Cellcura AS
Vekst i Grenland
Innovation Norway
Investigators
Study Director: Jarl Kahn, Dr. Med Fertilitetsklinikken Sør
  More Information

Responsible Party: Hans Ivar Hanevik, PhD, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT00541892     History of Changes
Other Study ID Numbers: s-05249
14231(NSD)
First Submitted: October 9, 2007
First Posted: October 10, 2007
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Hans Ivar Hanevik, Sykehuset Telemark:
Cell Culture Techniques

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