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Protocols for Improved in Vitro Fertilization (IVF) Outcomes

Primary Purpose

Infertility

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Microflare protocol for IVF

Antagonist protocol for IVF

Demi-halt protocol for IVF

About this trial

This is an interventional treatment trial for Infertility focused on measuring 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

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of California, San Francisco

Outcomes

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

Full Information

NCT ID

NCT00334243

First Posted

June 6, 2006

Last Updated

October 5, 2011

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00334243

Brief Title

Protocols for Improved in Vitro Fertilization (IVF) Outcomes

Official Title

Protocol Evaluation for Improved In Vitro Fertilization Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

June 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Microflare protocol for IVF

Intervention Type

Drug

Intervention Name(s)

Antagonist protocol for IVF

Intervention Type

Drug

Intervention Name(s)

Demi-halt protocol for IVF

Primary Outcome Measure Information:

Title

Pregnancy Rate

Secondary Outcome Measure Information:

Title

Cycle Cancellation Rates

Title

Number of Oocytes Generated

Title

Number of Embryos Generated

Title

Serum hormonal evaluation

Title

Follicular fluid evaluation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcelle I Cedars, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

12. IPD Sharing Statement

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Protocols for Improved in Vitro Fertilization (IVF) Outcomes

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