GnRH Antagonist to Prepare Recipients for Embryo Transfer
Use of GnRH Antagonist (Cetrotide) Protocol, Instead of Agonist, to Prepare Recipients for Embryo Transfer
1 other identifier
interventional
130
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 12, 2007
CompletedFirst Posted
Study publicly available on registry
April 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 26, 2010
May 1, 2010
2.8 years
April 12, 2007
May 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Pregnancy Rate
Secondary Outcomes (1)
Delivery Rate
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institute for Human Reproduction (IHR)
Chicago, Illinois, 60657, United States
Institute for Human Reproduction (IHR)
Oakbrook Terrace, Illinois, 60181, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilan Tur-Kaspa, MD
President and Medical Director, Institute for Human Reproduction (IHR) and Director, Clinical IVF-PGD Program, Reproductive Genetics Institute (RGI).
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 12, 2007
First Posted
April 16, 2007
Study Start
January 1, 2007
Primary Completion
October 1, 2009
Study Completion
December 1, 2009
Last Updated
May 26, 2010
Record last verified: 2010-05