Effects of Day 3 Blastomere Biopsy on Human Embryos

Early Phase 1

• Conditions: Blastomere Biopsy Safety
• Interventions: Procedure: Blastomere biopsy

• Registration Number: NCT01397487
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Last Update Submitted: 2011-07-27
• Last Update Posted: 2011-07-28
• Primary Completion: 2012-01
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 22

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
one single arm	Blastomere biopsy	All patients are included to complete a biopsy of half part of the embryos

Primary Outcome Measures

Name	Time	Method
Blastocyst percentage	after 120 hours of culture

Secondary Outcome Measures

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

Trial Locations

Locations (1)

La Fe University Hospital. Department of Obstetrics and Gynecology; 🇪🇸 Valencia, Spain