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Protocols for Improved in Vitro Fertilization (IVF) Outcomes

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Microflare protocol for IVF Drug: Antagonist protocol for IVF Drug: Demi-halt protocol for IVF Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocol Evaluation for Improved In Vitro Fertilization Outcomes
Study Start Date : June 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Pregnancy Rate

Secondary Outcome Measures :
  1. Cycle Cancellation Rates
  2. Number of Oocytes Generated
  3. Number of Embryos Generated
  4. Serum hormonal evaluation
  5. Follicular fluid evaluation

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334243


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Marcelle I Cedars, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00334243     History of Changes
Other Study ID Numbers: Purcell-01
First Posted: June 7, 2006    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011

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