Protocols for Improved in Vitro Fertilization (IVF) Outcomes
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Protocol Evaluation for Improved In Vitro Fertilization Outcomes |
- Pregnancy Rate
- Cycle Cancellation Rates
- Number of Oocytes Generated
- Number of Embryos Generated
- Serum hormonal evaluation
- Follicular fluid evaluation
| Enrollment: | 2 |
| Study Start Date: | June 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
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:
- Infertile patients
- Undergoing IVF
- Antral Follicle Count Less than 10
- Prior history of less than 5 oocytes generated during an IVF cycle
Contacts and Locations| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94115 | |
| Principal Investigator: | Marcelle I Cedars, MD | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00334243 History of Changes |
| Other Study ID Numbers: | Purcell-01 |
| Study First Received: | June 6, 2006 |
| Last Updated: | October 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
in vitro fertilization infertile infertility pregnancy pregnancy rates microflare protocol antagonist protocol |
demi-halt protocol poor responders 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:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013