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

Primary Purpose

In Vitro Fertilization, Infertility

Status
Withdrawn
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Medium with no human serum albumine added
Conventional medium
Sponsored by
Sykehuset Telemark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for In Vitro Fertilization focused on measuring Cell Culture Techniques

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fertilitetsklinikken Sør

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Medium with no human serum albumine added

Conventional medium

Outcomes

Primary Outcome Measures

Fertilization
Cleavage
Embryo score
Embryos used

Secondary Outcome Measures

Full Information

First Posted
October 9, 2007
Last Updated
May 19, 2015
Sponsor
Sykehuset Telemark
Collaborators
Cellcura AS, Vekst i Grenland, Innovation Norway
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1. Study Identification

Unique Protocol Identification Number
NCT00541892
Brief Title
Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine
Official Title
Sibling Oocyte Study of Medium for IVF/ICSI With no Human Serum Albumine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
senior coworker retired
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset Telemark
Collaborators
Cellcura AS, Vekst i Grenland, Innovation Norway

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In Vitro Fertilization, Infertility
Keywords
Cell Culture Techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Medium with no human serum albumine added
Arm Title
2
Arm Type
Active Comparator
Arm Description
Conventional medium
Intervention Type
Other
Intervention Name(s)
Medium with no human serum albumine added
Intervention Description
See above
Intervention Type
Other
Intervention Name(s)
Conventional medium
Intervention Description
See above
Primary Outcome Measure Information:
Title
Fertilization
Time Frame
24 hours
Title
Cleavage
Time Frame
48 hours
Title
Embryo score
Time Frame
48 hours
Title
Embryos used
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarl Kahn, Dr. Med
Organizational Affiliation
Fertilitetsklinikken Sør
Official's Role
Study Director
Facility Information:
Facility Name
Fertilitetsklinikken Sør
City
Porsgrunn
State/Province
Telemark
ZIP/Postal Code
3901
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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