NCT00334243

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

June 6, 2006

Last Update Submit

October 5, 2011

Conditions

Infertility

Keywords

in vitro fertilizationinfertileinfertilitypregnancypregnancy ratesmicroflare protocolantagonist protocoldemi-halt protocolpoor responderslow antral follicle countInfertile Patients undergoing in vitro fertilization (IVF)Patients with a previous poor response to ovarian stimulationPatients with an antral follicle count of less than 10

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Rate

Secondary Outcomes (5)

  • Cycle Cancellation Rates

  • Number of Oocytes Generated

  • Number of Embryos Generated

  • Serum hormonal evaluation

  • Follicular fluid evaluation

Interventions

Microflare protocol for IVFDRUG
Antagonist protocol for IVFDRUG
Demi-halt protocol for IVFDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile patients
  • Undergoing IVF
  • Antral Follicle Count Less than 10
  • Prior history of less than 5 oocytes generated during an IVF cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Marcelle I Cedars, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2006

First Posted

June 7, 2006

Study Start

June 1, 2006

Primary Completion

August 1, 2007

Study Completion

November 1, 2007

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

US(1)