Elsevier

Fertility and Sterility

Volume 100, Issue 3, September 2013, Pages 624-630
Fertility and Sterility

Seminal contribution
Cleavage-stage biopsy significantly impairs human embryonic implantation potential while blastocyst biopsy does not: a randomized and paired clinical trial

https://doi.org/10.1016/j.fertnstert.2013.04.039Get rights and content
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Objective

To determine if cleavage- or blastocyst-stage embryo biopsy affects reproductive competence.

Design

Paired randomized clinical trial.

Setting

Academic-assisted reproduction program.

Patient(s)

Attempting conception through IVF.

Intervention(s)

After selecting two embryos for transfer, one was randomized to biopsy and the other to control. Both were transferred within shortly thereafter. The biopsy was submitted for microarray analysis and single-nucleotide polymorphism (SNP) profiling. Buccal DNA obtained from the neonate after delivery had microarray analysis and SNP profile compared with that of the embryonic DNA. A match confirmed that the biopsied embryo implanted and developed to term, whereas a nonmatch indicated that the control embryo had led to the delivery.

Main Outcome Measure(s)

Paired analysis of the delivery rates of the transferred embryos. Either twin delivery or failure to deliver represents equivalent outcomes for the biopsied and control embryos. In contrast, singletons were determined to be from the biopsied or the control embryo.

Result(s)

Blastomere biopsy on day 3 of development resulted in a significant reduction in sustained implantation. Only 30% of biopsied embryos had sustained implantation and ultimately developed into live-born infants versus 50% of unbiopsied controls, a relative reduction of 39%. In contrast, sustained implantation rates were equivalent (51% vs. 54%) for biopsied and control blastocysts.

Conclusion(s)

Cleavage-stage biopsy markedly reduced embryonic reproductive potential. In contrast, trophectoderm biopsy had no measurable impact and may be used safely when embryo biopsy is indicated.

Clinical Trial Registration Number

NCT01219504.

Key Words

Embryo biopsy
IVF
preimplantation genetic diagnosis
DNA fingerprinting

Cited by (0)

R.T.S. received a grant from Serono Legacy by which medications were provided to study participants and has received payment from EMD Serono, Ferring, and Merck USA for lectures at medical meetings. K.M.U. and E.J.F. received a grant from Ferring Pharmaceuticals that provided gonadotropin injections and funding for all of the other study medications. T.Z. has nothing to disclose. N.R.T. has received payment from the American Society for Reproductive Medicine, Japan Society of Assisted Reproduction, Penn State University, Washington State University, Mayo Clinic, Applied Biosystems, Texas ART Society, and American Association of Bioanalysts for lectures and from the American Society for Reproductive Medicine for development of educational presentations, and has a patent pending.