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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01219504
First received: October 8, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition
Each Patient is Both Case and Control
1 Embryo Will be Biopsied and 1 Embryo is Not

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF

Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • Impact of biopsy on pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Impact of the biopsy of the embryo on whether a pregnancy is obtained

  • Impact of biopsy on delivery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Impact of the biopsy on pregnancy resulting in delivery


Biospecimen Retention:   Samples With DNA

Blood samples on female and male patients. Buccal swabs on infant(s).


Enrollment: 200
Study Start Date: April 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219504

Locations
United States, Connecticut
Reproductive Medicine Associates of Connecticut
Norfolk, Connecticut, United States, 06850
United States, New Jersey
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, United States, 07960
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
  More Information

Additional Information:
Reproductive Medicine Associates of New Jersey  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01219504     History of Changes
Other Study ID Numbers: RMA-00-17
Study First Received: October 8, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Medicine Associates of New Jersey:
PGD
IVF

ClinicalTrials.gov processed this record on May 16, 2013