Back to resultsGnRH Antagonist to Prepare Recipients for Embryo Transfer
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GnRH Antagonist (Cetrotide)
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Frozen embryo transfers (FET)., Egg donation (ED)., IVF., ART., Implantation., GnRH antagonist., Cetrotide., Endometrial response., Infertility treatments:, Transfer of embryos from egg donation (ED) to recipients.
Eligibility Criteria
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.
Sites / Locations
- Institute for Human Reproduction (IHR)
- Institute for Human Reproduction (IHR)
Outcomes
Primary Outcome Measures
Clinical Pregnancy Rate
Secondary Outcome Measures
Delivery Rate
Full Information
NCT ID
NCT00460642
First Posted
April 12, 2007
Last Updated
May 24, 2010
Sponsor
Institute for Human Reproduction (IHR)
1. Study Identification
Unique Protocol Identification Number
NCT00460642
Brief Title
GnRH Antagonist to Prepare Recipients for Embryo Transfer
Official Title
Use of GnRH Antagonist (Cetrotide) Protocol, Instead of Agonist, to Prepare Recipients for Embryo Transfer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute for Human Reproduction (IHR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Frozen embryo transfers (FET)., Egg donation (ED)., IVF., ART., Implantation., GnRH antagonist., Cetrotide., Endometrial response., Infertility treatments:, Transfer of embryos from egg donation (ED) to recipients.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GnRH Antagonist (Cetrotide)
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Secondary Outcome Measure Information:
Title
Delivery Rate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Tur-Kaspa, MD
Organizational Affiliation
President and Medical Director, Institute for Human Reproduction (IHR) and Director, Clinical IVF-PGD Program, Reproductive Genetics Institute (RGI).
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Human Reproduction (IHR)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Institute for Human Reproduction (IHR)
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.infertilityIHR.com
Description
Related Info
Learn more about this trial
GnRH Antagonist to Prepare Recipients for Embryo Transfer
We'll reach out to this number within 24 hrs