Effects of Day 3 Blastomere Biopsy on Human Embryos

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-09-30

Brief Summary

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

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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.

Conditions

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Blastomere Biopsy Safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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one single arm

All patients are included to complete a biopsy of half part of the embryos

Group Type OTHER

Blastomere biopsy

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No