- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00334243
Protocols for Improved in Vitro Fertilization (IVF) Outcomes
October 5, 2011 updated by: University of California, San Francisco
Protocol Evaluation for Improved In Vitro Fertilization Outcomes
Many infertile patients have a decreased chance of becoming pregnant when using in vitro fertilization (IVF).
For these patients, many different treatments are available, but none of them have been shown to be better than the others.
We are testing which of three different treatments are better than the others.
Patients who are expected to have a decreased response to ovarian stimulation will be randomized to either a microflare protocol, an antagonist protocol, or a demi-halt protocol.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Infertile patients with an anticipated poor response to ovarian stimulation will be randomized to one of three different protocols in their upcoming IVF cycle.
Each of the protocols will be performed as is the standard of care with the addition of serum evaluation during the course of the stimulation as well as follicular fluid analysis which is obtained as a byproduct of the oocyte retrieval.
Chart review will be performed to collect background characteristics (including age, ethnicity, previous fertility treatment), treatment response (such as oocyte number, embryo grade, embryo quality), and pregnancy outcome (such as miscarriage, singleton pregnancy, or higher-order multiple pregnancy).
Statistical analysis will be performed to determine if one protocol leads to higher pregnancy rates and multivariate analysis will be performed to determine potential etiologic variables.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 4
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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California
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San Francisco, California, United States, 94115
- University of California, San Francisco
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-
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
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Infertile patients
- Undergoing IVF
- Antral Follicle Count Less than 10
- Prior history of less than 5 oocytes generated during an IVF cycle
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: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Pregnancy Rate
|
Secondary Outcome Measures
Outcome Measure |
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Cycle Cancellation Rates
|
Number of Oocytes Generated
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Number of Embryos Generated
|
Serum hormonal evaluation
|
Follicular fluid evaluation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marcelle I Cedars, MD, University of California, San Francisco
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
June 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
June 6, 2006
First Submitted That Met QC Criteria
June 6, 2006
First Posted (Estimate)
June 7, 2006
Study Record Updates
Last Update Posted (Estimate)
October 6, 2011
Last Update Submitted That Met QC Criteria
October 5, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
- infertility
- pregnancy
- in vitro fertilization
- pregnancy rates
- poor responders
- antagonist protocol
- infertile
- microflare protocol
- demi-halt protocol
- low antral follicle count
- Infertile Patients undergoing in vitro fertilization (IVF)
- Patients with a previous poor response to ovarian stimulation
- Patients with an antral follicle count of less than 10
Additional Relevant MeSH Terms
Other Study ID Numbers
- Purcell-01
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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