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Protocols for Improved in Vitro Fertilization (IVF) Outcomes

Protocol Evaluation for Improved In Vitro Fertilization Outcomes

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00334243
Enrollment
2
Registered
2006-06-07
Start date
2006-06-30
Completion date
2007-11-30
Last updated
2011-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGMicroflare protocol for IVF
DRUGDemi-halt protocol for IVF

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Pregnancy Rate

Secondary

MeasureTime frame
Cycle Cancellation Rates
Number of Oocytes Generated
Number of Embryos Generated
Serum hormonal evaluation
Follicular fluid evaluation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026