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
  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:


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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 26, 2014