Effects of Day 3 Blastomere Biopsy on Human Embryos (BB)
Recruitment status was: Recruiting
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Effects of the Blastomere Biopsy of Day 3 Human Embryos on Blastocyst Percentage, Cell Number of Obtained Blastocyst and Implantation Rate|
- Blastocyst percentage [ Time Frame: after 120 hours of culture ] [ Designated as safety issue: Yes ]
- Number of cells of blastocyst measured by morphometric analysis [ Time Frame: after 120 hours of culture ] [ Designated as safety issue: Yes ]
- Implantation rate [ Time Frame: after one month of embryo transfer. ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
one single arm
All patients are included to complete a biopsy of half part of the embryos
Procedure: Blastomere biopsy
The blastomere biopsy will be done after 72 hours of embryo culture. An inverted microscope Olympus IX70 with a heated stage will be used to perform the biopsy. The micromanipulation for the blastomere extraction will be made with a micropipette MBB-FP-M-30 (Humagen).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397487
|La Fe University Hospital. Department of Obstetrics and Gynecology|
|Valencia, Spain, 46026|
|Study Director:||Antonio Pellicer, MDPhD||La Fe Hospital. Dept. of Obstetrics and Gynecology.|
|Study Chair:||Amparo Mercader, P.h.D||Instituto Valenciano de Infertilidad. PGD Laboratory.|