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Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)

Sponsor
Reproductive Medicine Associates of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT01219504
Collaborator
(none)
200
Enrollment
3
Locations
53
Duration (Months)
66.7
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the impact of embryo biopsy on the reproductive potential of human embryos.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study will recruit patients from the NY/NJ/CT/eastern PA area only.

    All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.

    On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.

    Following delivery, buccal swabs will be collected from infants.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF
    Study Start Date :
    Apr 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Sep 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Impact of biopsy on pregnancy [1 year]

      Impact of the biopsy of the embryo on whether a pregnancy is obtained

    2. Impact of biopsy on delivery [1 year]

      Impact of the biopsy on pregnancy resulting in delivery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    This study will recruit patients from the NY/NJ/CT/eastern PA area only.

    Inclusion Criteria:

    1. Maximum of one prior failed IVF treatment cycle

    2. Female partner less than 35 years of age

    3. Normal day 3 FSH level (<10 miu/mL)

    4. Total basal antral follicle count greater than or equal to 12

    5. Male partner with greater than 100,000 total motile spermatozoa and at least 1% normal forms

    6. Body mass index (BMI) < or = 32

    7. Normal uterine cavity

    Exclusion Criteria:

    1. Diagnosis of chronic anovulation secondary to polycystic ovarian disease

    2. Diagnosis of endometrial insufficiency

    3. Clinical indication for pre-implantation genetic diagnosis (PGD) (undergoing IVF with PGD to rule out a known genetic defect)

    4. Use of testicular aspiration or biopsy procedures to obtain sperm

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Reproductive Medicine Associates of Connecticut Norfolk Connecticut United States 06850
    2 Reproductive Medicine Associates of New Jersey Morristown New Jersey United States 07960
    3 Reproductive Medicine Associates of New York New York New Jersey United States 10022

    Sponsors and Collaborators

    • Reproductive Medicine Associates of New Jersey

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Reproductive Medicine Associates of New Jersey
    ClinicalTrials.gov Identifier:
    NCT01219504
    Other Study ID Numbers:
    • RMA-00-17
    First Posted:
    Oct 13, 2010
    Last Update Posted:
    Jan 23, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Reproductive Medicine Associates of New Jersey
    PGD
    IVF

    Study Results

    No Results Posted as of Jan 23, 2013