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

NCT ID: NCT00541892

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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In Vitro Fertilization Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Medium with no human serum albumine added

Group Type EXPERIMENTAL

Medium with no human serum albumine added

Intervention Type OTHER

See above

2

Conventional medium

Group Type ACTIVE_COMPARATOR

Conventional medium

Intervention Type OTHER

See above

Interventions

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Medium with no human serum albumine added

See above

Intervention Type OTHER

Conventional medium

See above

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cellcura AS

INDUSTRY

Sponsor Role collaborator

Vekst i Grenland

UNKNOWN

Sponsor Role collaborator

Innovation Norway

UNKNOWN

Sponsor Role collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hans Ivar Hanevik

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jarl Kahn, Dr. Med

Role: STUDY_DIRECTOR

Fertilitetsklinikken Sør

Locations

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Fertilitetsklinikken Sør

Porsgrunn, Telemark, Norway

Site Status

Countries

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Norway

Other Identifiers

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14231(NSD)

Identifier Type: -

Identifier Source: secondary_id

s-05249

Identifier Type: -

Identifier Source: org_study_id

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