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Effects of Day 3 Blastomere Biopsy on Human Embryos

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01397487
Acronym
BB
Enrollment
22
Registered
2011-07-19
Start date
2011-07-31
Completion date
2013-09-30
Last updated
2011-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blastomere Biopsy Safety

Keywords

morphometric parameters, embryo biopsy

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.

Interventions

PROCEDUREBlastomere 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).

Sponsors

Fundacion Para La Investigacion Hospital La Fe
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Blastocyst percentageafter 120 hours of culture

Secondary

MeasureTime frame
Number of cells of blastocyst measured by morphometric analysisafter 120 hours of culture
Implantation rateafter one month of embryo transfer.

Countries

Spain

Contacts

Primary ContactInmaculada Molina Botella, P.h.D
mamobo1@dca.upv.es0034 961244660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026