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

Sponsor

Sykehuset Telemark (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00541892

Collaborator

Cellcura AS (Industry), Vekst i Grenland (Other), Innovation Norway (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Fertilization [24 hours]
Cleavage [48 hours]
Embryo score [48 hours]
Embryos used [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hans Ivar Hanevik, PhD, Sykehuset Telemark

ClinicalTrials.gov Identifier:

NCT00541892

Other Study ID Numbers:

s-05249
14231(NSD)

First Posted:

Oct 10, 2007

Last Update Posted:

May 20, 2015

Last Verified:

May 1, 2015

Keywords provided by Hans Ivar Hanevik, PhD, Sykehuset Telemark

Cell Culture Techniques

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of May 20, 2015