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

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

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

Study Overview

• Status: Unknown
• Conditions: Blastomere Biopsy Safety
• Intervention / Treatment: Procedure: Blastomere biopsy

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
• Enrollment (Anticipated): 22
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Inmaculada Molina Botella, P.h.D; Phone Number: 0034 961244660; Email: mamobo1@dca.upv.es

Study Locations

• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • La Fe University Hospital. Department of Obstetrics and Gynecology
    • Contact: Inmaculada Molina Botella, P.h.D; Phone Number: 0034 619777030; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blastocyst percentage	after 120 hours of culture

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of cells of blastocyst measured by morphometric analysis	after 120 hours of culture
Implantation rate	after one month of embryo transfer.

Collaborators and Investigators

• Sponsor: 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2011
• Last Update Submitted That Met QC Criteria: July 27, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: morphometric parameters, embryo biopsy
• Other Study ID Numbers: 2009/0416