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

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ClinicalTrials.gov Identifier: NCT01219283
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Brief Summary:
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).

Condition or disease
Effect of PGD on Implantation Rates in IVF Cycles

Detailed Description:

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).

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Study Type : Observational
Actual Enrollment : 334 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis
Study Start Date : August 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Group/Cohort
Control (no PGD)
Receive their planned IVF treatment without PGD. 2 morphologically best embryos are transferred.
Case (PGD)
Receive PGD in addition to their planned IVF Cycle. 2 morphologically best PGD normal embryos are transferred.



Primary Outcome Measures :
  1. Sustained Implantation Rate Per Embryo Transferred [ Time Frame: Within 1 year ]
    Implantation rate per embryo transferred


Secondary Outcome Measures :
  1. Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle [ Time Frame: Within 1 Year ]
    Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle


Biospecimen Retention:   Samples With DNA
Blood samples from the male and female partners. Buccal swabs from infants.


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
500 patients attempting conception through IVF who have a maximum of one prior failed IVF cycle.
Criteria

Major 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

Major 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219283


Locations
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United States, Colorado
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, United States, 18104
United States, New Jersey
Reproductive Medicine Associates
Morristown, New Jersey, United States, 07960
United States, Pennsylvania
Reproductive Medicine Associates of PA at Lehigh Valley
Allentown, Pennsylvania, United States, 18104
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
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Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01219283    
Other Study ID Numbers: RCT-2009-01
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Keywords provided by Reproductive Medicine Associates of New Jersey:
PGD
IVF