IVF Clinical Trial of Two Different Treatment Protocols.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficiency and Patient Satisfaction of Two Different IVF Protocols.

Conditions
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Infertility

Intervention / Treatment
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* Other: in vitro fertilization (IVF/ICSI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARM A - Mini IVF<br>The Mini IVF method entails pre-treatment with oral contraceptive pills. Ovarian stimulation is achieved using an oral anti-estrogen in conjunction with injections of gonadotropin (225IU-600IU per cycle), with initial dose of 75IU-150IU per injection. Ovulation is induced by a GnRH (gonadotropin-releasing hormone) agonist nasal spray/hCG (human chorionic gonadotropin) injection. Retrieved oocytes following in vitro fertilization (IVF/ICSI) are cultured to the blastocyst stage. Blastocyst stage embryos are vitrified using the CryoTop method. No fresh embryo transfer is conducted. Subsequently, SET of a thawed blastocyst is performed in a natural cycle/HRT that does not involve ovarian stimulation. SETs are conducted until pregnancy is achieved or all vitrified blastocysts have been used. | Other: in vitro fertilization (IVF/ICSI)<br> <br> |
| Active Comparator: Arm B - Conventional IVF<br>The standard IVF method entails pre-treatment with a GnRH analog injections in the midluteal phase. Controlled ovarian hyperstimulation is achieved with injections of gonadotropin (150IU-300IU/day). Ovulation is induced by hCG injection and retrieved oocytes following in vitro fertilization (IVF/ICSI) are cultured to the blastocyst stage. If this occurs on day 5, then fresh SET/DET (single embryo transfer/double embryo transfer) is performed. Remaining blastocysts are cryopreserved and transferred in subsequent natural cycles/HRT (hormone replacement therapy) that does not involve ovarian stimulation. | Other: in vitro fertilization (IVF/ICSI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome parameter: Live birth |  | 4 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome parameters: Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Multiple pregnancy rate, Miscarriage rate, Fertilization rate, Number of oocytes, Number of embryos |  | 4 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF Research Study, Infertility Sudy, in vitro fertilization, Mini IVF, Conventional IVF