Effects of Day 3 Blastomere Biopsy on Human Embryos

Blastomere Biopsy Safety Clinical Trial

— BB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01397487
• Other study ID #: 2009/0416
• Status: Recruiting
• Phase: Phase 0
• First received: July 18, 2011
• Last updated: July 27, 2011
• Start date: July 2011
• Est. completion date: September 2013

Study information

• Verified date: July 2011
• Source: Fundacion Para La Investigacion Hospital La Fe
• Contact: Inmaculada Molina Botella, P.h.D
• Phone: 0034 961244660
• Email: mamobo1[@]dca.upv.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: September 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blastomere Biopsy Safety

Intervention

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).

Locations

Country	Name	City	State
Spain	La Fe University Hospital. Department of Obstetrics and Gynecology	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Para La Investigacion Hospital La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastocyst percentage		after 120 hours of culture	Yes
Secondary	Number of cells of blastocyst measured by morphometric analysis		after 120 hours of culture	Yes
Secondary	Implantation rate		after one month of embryo transfer.	Yes