Protocols for Improved in Vitro Fertilization (IVF) Outcomes

• ClinicalTrials.gov Identifier: NCT00334243
• Recruitment Status: Terminated
• First Posted: June 7, 2006
• Last Update Posted: October 6, 2011
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: June 6, 2006
• First Posted Date: June 7, 2006
• Last Update Posted Date: October 6, 2011
• Study Start Date: June 2006
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 6, 2006): Pregnancy Rate
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Protocols for Improved in Vitro Fertilization (IVF) Outcomes
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Infertility

Intervention

• Drug: Microflare protocol for IVF
• Drug: Antagonist protocol for IVF
• Drug: Demi-halt protocol for IVF

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 5, 2011): 2
• Original Enrollment (submitted: June 6, 2006): 2011
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00334243
• Other Study ID Numbers: Purcell-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marcelle I Cedars, MD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: October 2011