Protocols for Improved in Vitro Fertilization (IVF) Outcomes

Phase 4

Terminated

• Conditions: Infertility

• Registration Number: NCT00334243
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-06
• Study First Submitted QC: 2006-06-06
• Study First Posted: 2006-06-07
• Primary Completion: 2007-08
• Study Completion: 2007-11
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate

Secondary Outcome Measures

Name	Time	Method
Follicular fluid evaluation
Cycle Cancellation Rates
Number of Oocytes Generated
Number of Embryos Generated
Serum hormonal evaluation

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States