Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Protocols for Improved in Vitro Fertilization (IVF) Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334243
Recruitment Status : Terminated (stopped due to limited enrollment. 2 subjects were enrolled. There was NO enrollment after November 2007.)
First Posted : June 7, 2006
Last Update Posted : October 6, 2011
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE June 6, 2006
First Posted Date  ICMJE June 7, 2006
Last Update Posted Date October 6, 2011
Study Start Date  ICMJE June 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2006)
Pregnancy Rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2006)
  • Cycle Cancellation Rates
  • Number of Oocytes Generated
  • Number of Embryos Generated
  • Serum hormonal evaluation
  • Follicular fluid evaluation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protocols for Improved in Vitro Fertilization (IVF) Outcomes
Official Title  ICMJE Protocol Evaluation for Improved In Vitro Fertilization Outcomes
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Microflare protocol for IVF
  • Drug: Antagonist protocol for IVF
  • Drug: Demi-halt protocol for IVF
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 5, 2011)
2
Original Enrollment  ICMJE
 (submitted: June 6, 2006)
2011
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infertile patients
  • Undergoing IVF
  • Antral Follicle Count Less than 10
  • Prior history of less than 5 oocytes generated during an IVF cycle
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00334243
Other Study ID Numbers  ICMJE Purcell-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcelle I Cedars, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP