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Clinical Trials/NCT00334243
NCT00334243
Terminated
Phase 4

Protocol Evaluation for Improved In Vitro Fertilization Outcomes

University of California, San Francisco1 site in 1 country2 target enrollmentJune 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Infertility
Sponsor
University of California, San Francisco
Enrollment
2
Locations
1
Primary Endpoint
Pregnancy Rate
Status
Terminated
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
November 2007
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pregnancy Rate

Secondary Outcomes

  • Cycle Cancellation Rates
  • Number of Oocytes Generated
  • Number of Embryos Generated
  • Serum hormonal evaluation
  • Follicular fluid evaluation

Study Sites (1)

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