- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00608010
Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis
February 5, 2008 updated by: V.K.V. American Hospital, Istanbul
Embryo preservation through freezing plays a significant role in human assisted reproduction.
It provides an opportunity for patients to have more than one attempt following an ovarian stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins and improving cumulative pregnancy rates.
The purpose of this study is to compare effectiveness of two different freezing methods.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
186
Phase
- Not Applicable
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
-
-
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Istanbul, Turkey, 34365
- American Hospital of Istanbul
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ICSI with own gametes
- Couples who did not wish to cryopreserve their excess embryos for possible transfer in a future cyle
- Donating excess embryos for research purposes
Exclusion Criteria:
- Embryos derived from surgically retrieved spermatozoa
- Blastocysts
- Embryos of low quality (Grade 3 or 4 according to Hardarson)
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Vitrification
|
Embryos were vitrified according to a previously described technique
|
Active Comparator: 2
Slow freezing
|
Embryos were frozen with slow freezing technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blastocyst development rate
Time Frame: 3 days after thawing
|
3 days after thawing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Basak Balaban, BSc, American Hospital of Istanbul
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2006
Primary Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
January 22, 2008
First Submitted That Met QC Criteria
February 5, 2008
First Posted (Estimate)
February 6, 2008
Study Record Updates
Last Update Posted (Estimate)
February 6, 2008
Last Update Submitted That Met QC Criteria
February 5, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- AH-ART-06/13
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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