NCT00541892

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

6.3 years

First QC Date

October 9, 2007

Last Update Submit

May 19, 2015

Conditions

In Vitro FertilizationInfertility

Keywords

Cell Culture Techniques

Outcome Measures

Primary Outcomes (4)

  • Fertilization

    24 hours

  • Cleavage

    48 hours

  • Embryo score

    48 hours

  • Embryos used

    48 hours

Study Arms (2)

1

EXPERIMENTAL

Medium with no human serum albumine added

Other: Medium with no human serum albumine added

2

ACTIVE COMPARATOR

Conventional medium

Other: Conventional medium

Interventions

Medium with no human serum albumine addedOTHER

See above

1
Conventional mediumOTHER

See above

2

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Low responders to FSH.
  • Females in danger of developing OHSS.
  • Sperm sample below ICSI-quality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertilitetsklinikken Sør

Porsgrunn, Telemark, 3901, Norway

Location

MeSH Terms

Conditions

Infertility

Interventions

Culture Media

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Laboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and UsesEquipment and Supplies

Study Officials

  • Jarl Kahn, Dr. Med

    Fertilitetsklinikken Sør

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 10, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

NO(1)