IVF Clinical Trial of Two Different Treatment Protocols.

Efficiency and Patient Satisfaction of Two Different IVF Protocols.

The purpose of this study is to compare two different in vitro fertilization (IVF) treatments: conventional IVF protocol and minimal stimulation IVF protocol, in terms of success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost of treatment.

A random population of 564 sub-fertile women or couples with a female between ages of 18 and 38 years and a desire to undergo their first IVF cycle will be included in this outpatient clinical trial. The participation in this study will be approximately six months with a total of 20 to 25 visits. After successful completion of the pre-screening tests participants are randomized into one of the two arms of the study: Arm A - mini IVF protocol, and Arm B - conventional IVF protocol.

Inclusion criteria:

• Valid indication for IVF treatment
• First IVF attempt
• Female age between 18 and 38 years
• Male partner 18 years of age or older
• Both partners STD free
• Must be able to understand that they may NOT become pregnant

Exclusion criteria:

• Not willing or able to sign the consent form
• Pre-existing medical condition preventing/interfering with IVF treatment
• Abnormal IVF screening tests, which includes Complete Blood Count, Varicella titer, Rubella titer, PAP smear, Syphilis, HIV 1&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea
• Abnormal pap smear
• Body Mass Index (BMI) falls below 18.5 or above 32.0
• Female participant with irregular menstrual cycles