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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

October 8, 2010
January 22, 2013
April 2008
September 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01219504 on ClinicalTrials.gov Archive Site
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Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
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.

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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples on female and male patients. Buccal swabs on infant(s).
Non-Probability Sample

200 infertile couples undergoing IVF will be enrolled in the study.
  • Each Patient is Both Case and Control
  • 1 Embryo Will be Biopsied and 1 Embryo is Not
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01219504
RMA-00-17
No
Reproductive Medicine Associates of New Jersey
Reproductive Medicine Associates of New Jersey
Not Provided
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey
Reproductive Medicine Associates of New Jersey
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP