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

January 22, 2013 updated by: Reproductive Medicine Associates of New Jersey

Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

200

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
    • Connecticut
      • Norfolk, Connecticut, United States, 06850
        • Reproductive Medicine Associates of Connecticut
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Reproductive Medicine Associates of new Jersey
      • New York, New Jersey, United States, 10022
        • Reproductive Medicine Associates of New York

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 infertile couples undergoing IVF will be enrolled in the study.

Description

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

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

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of biopsy on pregnancy
Time Frame: 1 year
Impact of the biopsy of the embryo on whether a pregnancy is obtained
1 year
Impact of biopsy on delivery
Time Frame: 1 year
Impact of the biopsy on pregnancy resulting in delivery
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

April 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

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)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMA-00-17

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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