GnRH Antagonist to Prepare Recipients for Embryo Transfer - NCT00460642-60657 (Clinical Trial 168334)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy168334.aspx
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Chicago |
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State:
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IL |
| Zip Code: |
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60657 |
| Conditions: |
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Infertility |
| Purpose: |
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26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers
(FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical
protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap
Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD
Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation
with ART treatment, and its usage decreases significantly the number of injections that the
patient receives with treatment. The working hypothesis for this study is that the GnRH
antagonist (Cetrotide) can be used instead of an agonist to achieve effective down
regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron
because of the markedly fewer injections required.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- History of infertility before cryopreserving the embryos or inability to conceive
from her own oocytes (based on age and/or a serum FSH > 15 IU/L).
- Any patient desiring to become pregnant as a result of transferring frozen-thawed
embryos generated using her own or donor oocytes.
- Subject is in good health as determined by the Investigator on the basis of medical
history, physical examination and laboratory screening tests.
- A negative pregnancy test prior to starting treatment with estrogens.
Exclusion Criteria:
- Women with a history of liver and/or kidney disease
- Hypertension: systolic pressure over 180 mm Hg or diastolic pressure over 105 at any
study visit, measured twice 6 hours apart despite active treatment for hypertension.
- Liver function tests of two times than the upper limit of normal
- Women with active sever endometriosis. |
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| Study is available at: |
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Institute for Human Reproduction (IHR)
Chicago, IL 60657
United States
Primary Contact:
Ilan Tur-Kaspa, MD
Phone: 773-472-4949
Secondary Contact:
Ilan Tur-Kaspa, MD
Phone: 773-472-4949 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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