Effects of Day 3 Blastomere Biopsy on Human Embryos (BB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397487
Recruitment Status : Unknown
Verified July 2011 by Fundacion Para La Investigacion Hospital La Fe.
Recruitment status was:  Recruiting
First Posted : July 19, 2011
Last Update Posted : July 28, 2011
Information provided by:
Fundacion Para La Investigacion Hospital La Fe

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

Condition or disease Intervention/treatment Phase
Blastomere Biopsy Safety Procedure: Blastomere biopsy Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. Blastocyst percentage [ Time Frame: after 120 hours of culture ]

Secondary Outcome Measures :
  1. Number of cells of blastocyst measured by morphometric analysis [ Time Frame: after 120 hours of culture ]
  2. Implantation rate [ Time Frame: after one month of embryo transfer. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • No relevant medical history.
  • BMI < 25.
  • 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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397487

Contact: Inmaculada Molina Botella, P.h.D 0034 961244660

La Fe University Hospital. Department of Obstetrics and Gynecology Recruiting
Valencia, Spain, 46026
Contact: Inmaculada Molina Botella, P.h.D    0034 619777030   
Sub-Investigator: Jose Pertusa, P.h.D         
Sub-Investigator: Ana Debón, P.h.D         
Sub-Investigator: Vicente Montañana, M.D         
Sub-Investigator: Jose Maria Rubio, P.h.D         
Sub-Investigator: Patrocinio Polo, M.D         
Sub-Investigator: Juan Vicente Martinez, Biologist         
Sponsors and Collaborators
Fundacion Para La Investigacion Hospital La Fe
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.

Responsible Party: FUNDACION PARA LA INVESTIGACION HOSPITAL LA FE, Hospital Universitari y Politecnic La Fe Identifier: NCT01397487     History of Changes
Other Study ID Numbers: 2009/0416
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by Fundacion Para La Investigacion Hospital La Fe:
morphometric parameters, embryo biopsy