Clinical trial NCT01397487: Effects of Day 3 Blastomere Biopsy on Human Embryos
Official title: Effects of the Blastomere Biopsy of Day 3 Human Embryos on Blastocyst Percentage, Cell Number of Obtained Blastocyst and Implantation Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Blastomere Biopsy Safety
Keywords: morphometric parameters, embryo biopsy
Lead sponsor: Fundacion Para La Investigacion Hospital La Fe
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Blastocyst percentage
timeFrame: after 120 hours of culture
Secondary outcomes:
measure: Number of cells of blastocyst measured by morphometric analysis
timeFrame: after 120 hours of culture
measure: Implantation rate
timeFrame: after one month of embryo transfer.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: La Fe University Hospital. Department of Obstetrics and Gynecology
Study officials:
affiliation: La Fe Hospital. Dept. of Obstetrics and Gynecology.
name: Antonio Pellicer, MDPhD
role: STUDY_DIRECTOR
affiliation: Instituto Valenciano de Infertilidad. PGD Laboratory.
name: Amparo Mercader, P.h.D
role: STUDY_CHAIR
References: