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

March 25, 2015 updated by: Reproductive Medicine Associates of New Jersey

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

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).

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

334

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Lone Tree, Colorado, United States, 18104
        • Colorado Center for Reproductive Medicine
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Reproductive Medicine Associates
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Reproductive Medicine Associates of PA at Lehigh Valley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

500 patients attempting conception through IVF who have a maximum of one prior failed IVF cycle.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Implantation Rate Per Embryo Transferred
Time Frame: Within 1 year
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
Time Frame: Within 1 Year
Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle
Within 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Richard T Scott, MD, Reproductive Medicine Associates of new Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCT-2009-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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