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| Sponsored by: |
University of California, San Francisco |
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00334243 |
Purpose
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.
| Condition | Intervention | Phase |
|
Infertility |
Drug: Microflare protocol for IVF Drug: Antagonist protocol for IVF Drug: Demi-halt protocol for IVF |
Phase IV |
| MedlinePlus related topics: | Infertility |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Protocol Evaluation for Improved In Vitro Fertilization Outcomes |
| Estimated Enrollment: | 2011 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | January 2016 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Marcelle I. Cedars, MD | 415-353-7475 | cedarsm@obgyn.ucsf.edu |
| United States, California | |||||
| University of California, San Francisco | Recruiting | ||||
| San Francisco, California, United States, 94115 | |||||
| Contact: Marcelle I. Cedars, MD 415-353-7475 cedarsm@obgyn.ucsf.edu | |||||
| Contact: Marcelle I Cedars, MD 415-353-7475 marcelle.cedars@ucsfmedctr.org | |||||
| Principal Investigator: Marcelle I. Cedars, MD | |||||
| Sub-Investigator: Karen J. Purcell, MD/PhD | |||||
| University of California, San Francisco |
| Principal Investigator: | Marcelle I Cedars, MD | University of California, San Francisco |
More Information
| Study ID Numbers: | Purcell-01 |
| First Received: | June 6, 2006 |
| Last Updated: | September 20, 2006 |
| ClinicalTrials.gov Identifier: | NCT00334243 |
| Health Authority: | United States: Institutional Review Board |
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