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Clinical Trials/NCT01397487
NCT01397487
Unknown
Early Phase 1

Effects of the Blastomere Biopsy of Day 3 Human Embryos on Blastocyst Percentage, Cell Number of Obtained Blastocyst and Implantation Rate

Fundacion Para La Investigacion Hospital La Fe1 site in 1 country22 target enrollmentJuly 2011

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Blastomere Biopsy Safety
Sponsor
Fundacion Para La Investigacion Hospital La Fe
Enrollment
22
Locations
1
Primary Endpoint
Blastocyst percentage
Last Updated
14 years ago

Overview

Brief Summary

The aim of this study to evaluate the effect of embryo biopsy on blastocyst development and implantation rate.

Detailed Description

Preimplantation genetic diagnosis (PGD) was initially developed to prevent monogenic diseases. However, its use has been extended to improve pregnancy rates in assisted reproductive techniques (ART). These new indications has been called screening for aneuploidy (PGS, preimplantation genetic screening). The current indications for PGS include advanced maternal age, recurrent miscarriage, repeated implantation failure, severe male factor infertility, previous aneuploid pregnancy, poor embryo quality, chemotherapy and radiotherapy and elective single embryo transfer to avoid multiple pregnancies. Nevertheless, the results obtained in the last decade have failed to clearly demonstrate any benefit of PGS in these indications and there are no studies evaluating the effect that biopsy could produce on embryos. Markers of embryo quality are still very limited and are based on subjective morphological parameters (such as cell number, size and degree of fragmentation) or on the study of embryonic development by measuring the percentage of embryos reaching the blastocyst stage after 120 hours of in vitro culture. Counting the cell number of blastocysts involves the staining and subsequent nuclei counting, which is incompatible with later embryo transfer. A valid alternative to avoid nuclear staining would be a morphometric study using optical sections of different focal planes of the blastocyst and three dimensional (3D) virtual reconstructions.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
September 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Fundacion Para La Investigacion Hospital La Fe

Eligibility Criteria

Inclusion Criteria

  • No relevant medical history.
  • Age \< 35 years old.
  • Unexplained infertility, tubal or male cause of infertility.
  • Between 6 and 8 embryos on day 3 of embryo culture.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Blastocyst percentage

Time Frame: after 120 hours of culture

Secondary Outcomes

  • Number of cells of blastocyst measured by morphometric analysis(after 120 hours of culture)
  • Implantation rate(after one month of embryo transfer.)

Study Sites (1)

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