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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Fundacion Para La Investigacion Hospital La Fe.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier:
NCT01397487
First received: July 18, 2011
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Blastomere Biopsy Safety
Procedure: Blastomere biopsy
Phase 0

Study Type: Interventional
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

Further study details as provided by Fundacion Para La Investigacion Hospital La Fe:

Primary Outcome Measures:
  • Blastocyst percentage [ Time Frame: after 120 hours of culture ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 22
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)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397487

Contacts
Contact: Inmaculada Molina Botella, P.h.D 0034 961244660 mamobo1@dca.upv.es

Locations
Spain
La Fe University Hospital. Department of Obstetrics and Gynecology Recruiting
Valencia, Spain, 46026
Contact: Inmaculada Molina Botella, P.h.D    0034 619777030    mamobo1@dca.upv.es   
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
Investigators
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.
  More Information

No publications provided

Responsible Party: FUNDACION PARA LA INVESTIGACION HOSPITAL LA FE, Hospital Universitari y Politecnic La Fe
ClinicalTrials.gov Identifier: NCT01397487     History of Changes
Other Study ID Numbers: 2009/0416
Study First Received: July 18, 2011
Last Updated: July 27, 2011
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on August 28, 2014