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

May 19, 2015 updated by: Hans Ivar Hanevik, Sykehuset Telemark

Sibling Oocyte Study of Medium for IVF/ICSI With no 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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Telemark
      • Porsgrunn, Telemark, Norway, 3901
        • Fertilitetsklinikken Sør

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fertilization
Time Frame: 24 hours
24 hours
Cleavage
Time Frame: 48 hours
48 hours
Embryo score
Time Frame: 48 hours
48 hours
Embryos used
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Telemark

Collaborators

Cellcura AS
Vekst i Grenland
Innovation Norway

Investigators

  • Study Director: Jarl Kahn, Dr. Med, Fertilitetsklinikken Sør

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 9, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s-05249
  • 14231(NSD)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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