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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

334 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-06-30

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).

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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).

Conditions

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Effect of PGD on Implantation Rates in IVF Cycles

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control (no PGD)

Receive their planned IVF treatment without PGD. 2 morphologically best embryos are transferred.

No interventions assigned to this group

Case (PGD)

Receive PGD in addition to their planned IVF Cycle. 2 morphologically best PGD normal embryos are transferred.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age of female partner of \< 43 years
2. Normal day-three FSH level (\< 15 mIU/mL)
3. Normal uterine cavity
4. Sufficient ejaculated spermatozoa in male partner for ART
5. Maximum of one prior failed IVF cycle

Exclusion Criteria

1. FSH level ≥ 15 mIU/mL
2. BMI greater than 32 kg/m2
3. Contraindication to gonadotropin stimulation
4. Unevaluated Ovarian mass
5. Need for surgical sperm removal
6. Any contraindication to undergoing in vitro fertilization
7. Age greater than 43 years
8. Presence of hydrosalpinges which communicate with the endometrial cavity
9. Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)

Minimum Eligible Age

21 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes