Comparing Intra-vaginal Culture of Embryos to In-vitro Culture of Embryos With Minimal Stimulation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate implantation rate with intra-vaginal culture (IVC) with the INVOcell device versus traditional In-Vitro Fertilization (IVF) while using minimal stimulation protocols

Detailed Description
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This is a Phase IV, single center randomized controlled trial evaluating intra-vaginal culture (IVC) using INVOcell versus traditional In-Vitro Fertilization (IVF) using oral stimulation or minimal gonadotropin stimulation protocols. The pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (N=20) using INVOcell or to the traditional IVF group (N=20). Primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred. Secondary aims are: Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of Good, Fair or Poor. Fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. This comparison will take place on day-3, as that is when the IVC embryos will be assessed. Clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred. Live birth rate, which is defined by the number of living babies delivered divided by the number of transfers

Official Title
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Randomized Controlled Trial Comparing Intra-vaginal Culture of Embryos Using INVOcell Device to In-vitro Culture of Embryos Using Minimal Stimulation Protocols

Conditions
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Infertility

Intervention / Treatment
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* Device: INVOcell device
* Other: Traditional IVF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal uterine cavity One or more years of infertility Normal male partner semen analysis Exclusion Criteria: Age <18 years old or >37 years old Antral Follicle Count (AFC) <8 Abnormal male partner semen analysis or use of donor sperm Vaginal inflammation or genital (vaginal, uterine, tubal) infection Uncontrolled chronic disease (such as uncontrolled diabetes or hypertension) Uterine anatomic abnormalities Allergy to plastics or inability to use diaphragm retention device Untreated hydrosalpinx Current alcohol abuse (defined by >14 drinks/week) Prior history of IVF cycle where fertilization did not occur History of recurrent pregnancy loss

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Arm 1: intra-vaginal culture using INVOcell device. Arm 2: Traditional In-Vitro Fertilization (IVF) culture in an embryology laboratory
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-vaginal culture - INVOcell device<br>3 day intra-vaginal incubation using the INVOcell device | Device: INVOcell device<br>* intra-vaginal culture of embryos using INVOcell device<br>|
| Active Comparator: Traditional IVF culture<br>3 day traditional IVF incubation | Other: Traditional IVF<br>* traditional culture of embryos in-vitro<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation Rate | defined by number gestational sacs seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by number of embryos transferred | approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo Quality | -Embryo quality, which is measured by system similar to the Gardner grading system at cleavage stage. Reported quality will be converted to the simplified SART embryo scoring system which provides an overall categorical embryo grade of Good, Fair or Poor. | measured after 3 days of incubation | 
| Fertilization Rate | defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved | measured after 3 days of incubation | 
| Clinical Pregnancy Rate | which is defined by the number of fetal poles with heartbeat seen on early pregnancy ultrasound typically done at 6 weeks of gestational age divided by the number of embryos transferred | approximately 4 weeks following randomization. Clinically this is typically done around 6 weeks of gestational age | 
| Live Birth Rate | which is defined by the number of living babies delivered divided by the number of transfers | 9 months after embryo transfer |