Protocols for Improved in Vitro Fertilization (IVF) Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Protocol Evaluation for Improved In Vitro Fertilization Outcomes

Conditions
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Infertility

Intervention / Treatment
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* Drug: Microflare protocol for IVF
* Drug: Antagonist protocol for IVF
* Drug: Demi-halt protocol for IVF


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Microflare protocol for IVF|nan|
|Drug: Antagonist protocol for IVF|nan|
|Drug: Demi-halt protocol for IVF|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle Cancellation Rates |  |  | 
| Number of Oocytes Generated |  |  | 
| Number of Embryos Generated |  |  | 
| Serum hormonal evaluation |  |  | 
| Follicular fluid evaluation |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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