Effects of Day 3 Blastomere Biopsy on Human Embryos

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

Detailed Description
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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.

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

Conditions
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Blastomere Biopsy Safety

Intervention / Treatment
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* Procedure: Blastomere biopsy


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: one single arm<br>All patients are included to complete a biopsy of half part of the embryos | Procedure: Blastomere biopsy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst percentage |  | after 120 hours of culture | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morphometric parameters, embryo biopsy