Study of the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis (PGD)

Study Overview
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Brief Summary
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The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF).

Detailed Description
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FISH based PGD techniques have provided little improvement in implantation and delivery rates. We believe that the use of 24 chromosome PGD, as compared to control (no PGD) will show a benefit to patients. This study is a randomized clinical trial that seeks to validate 24 chromosome PGD. Patients that meet the eligibility criteria will be randomized prior to embryo transfer. In order to be randomized, the patient must have blastulated embryos suitable for biopsy on day 5. Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred. Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred. Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infant(s).

Official Title
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A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis

Conditions
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Effect of PGD on Implantation Rates in IVF Cycles

Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: Age of female partner of < 43 years Normal day-three FSH level (< 15 mIU/mL) Normal uterine cavity Sufficient ejaculated spermatozoa in male partner for ART Maximum of one prior failed IVF cycle Major Exclusion Criteria: FSH level ≥ 15 mIU/mL BMI greater than 32 kg/m2 Contraindication to gonadotropin stimulation Unevaluated Ovarian mass Need for surgical sperm removal Any contraindication to undergoing in vitro fertilization Age greater than 43 years Presence of hydrosalpinges which communicate with the endometrial cavity Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 43 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control (no PGD)<br>Receive their planned IVF treatment without PGD. 2 morphologically best embryos are transferred. | |
| Case (PGD)<br>Receive PGD in addition to their planned IVF Cycle. 2 morphologically best PGD normal embryos are transferred. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Implantation Rate Per Embryo Transferred | Implantation rate per embryo transferred | Within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle | Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle | Within 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PGD, IVF