Protocols for Improved in Vitro Fertilization (IVF) Outcomes

This study has been terminated.

(stopped due to limited enrollment. 2 subjects were enrolled. There was NO enrollment after November 2007.)

Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00334243

First received: June 6, 2006

Last updated: October 5, 2011

Last verified: October 2011

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Pregnancy Rate

Secondary Outcome Measures:

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)

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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

ClinicalTrials.gov processed this record on March 03, 2015

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