Side of Embryo Biopsy Interfering Implantation Potential

NCT ID: NCT02902614

Last Updated: 2019-01-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-02

Brief Summary

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Selection of side of embryo biopsy that will not interfering with implantation power of developed blastocyst embryo during biopsy procedure arranged for PGT.

Detailed Description

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During process of embryo biopsy, it was indicated to avoid contacting cells closer to inner cell mass as it can decrease the quality of embryo and its structural composition. However, recommendation for collection from the trophectoderm (TE) side is indicated.

Absence of differentiation during cleavage-stage or morula stage at day 3 and day 4 respectively, will present the needful to focus a specific location for embryo biopsy during pre-blastocyst stages for embryo going to do genetic testing before implantation or embryo transfer.

In articulation around the second polar body or the animal pole of embryo, collection of the cell from the vegetal pole in crospondence to avoide collection form the animal pole is to be compare the results of implantation for biopsy done using the animal pole side or the random non organized biosy procedure.

Conditions

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Preimplantation Diagnosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Vegetal Pole blastomer embryo

for day 3 embryo biopsy / cleavage stage: Blastomere collection from opposite side to the 2nd polar body or from vegetal pole.

Group Type EXPERIMENTAL

Vegetal Pole blastomer embryo

Intervention Type PROCEDURE

for day 3 embryo biopsy / cleavage stage

Animal Pole blastomer embryo

Intervention Type PROCEDURE

for day 3 embryo biopsy / cleavage stage

Animal Pole blastomer embryo

for day 3 embryo biopsy / cleavage stage: Blastomere collection from and side around the 2nd polar body and not the vegetal pole.

Group Type EXPERIMENTAL

Vegetal Pole blastomer embryo

Intervention Type PROCEDURE

for day 3 embryo biopsy / cleavage stage

Animal Pole blastomer embryo

Intervention Type PROCEDURE

for day 3 embryo biopsy / cleavage stage

Interventions

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Vegetal Pole blastomer embryo

for day 3 embryo biopsy / cleavage stage

Intervention Type PROCEDURE

Animal Pole blastomer embryo

for day 3 embryo biopsy / cleavage stage

Intervention Type PROCEDURE

Other Intervention Names

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Biopsy embryo from sides considered far from ICM location. Random biopsy without considering specific location

Eligibility Criteria

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Inclusion Criteria

* grade 1 or 2 embryos at eight cell stage or 8-1/ 8-2 embryo quality.

Exclusion Criteria

* grade 3 embryo at day 3, or 8-3 embryos.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ibn Sina Hospital

OTHER_GOV

Sponsor Role collaborator

Ahmad Mustafa Mohamed Metwalley

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Mustafa Mohamed Metwalley

IVF laboratory manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmad M Metwalley

Role: PRINCIPAL_INVESTIGATOR

Al Baraka Fertility Hospital

Locations

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AHMAD Barakat

Manama, , Bahrain

Site Status

Ibn Sina IVF Center- Ibn Sina Hospital

Sohag, , Egypt

Site Status

Countries

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Bahrain Egypt

References

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Tscherne RJ, Capitano G. High-pressure liquid chromatographic separation of pharmaceutical compounds using a mobile phase containing silver nitrate. J Chromatogr. 1977 Jun 11;136(2):337-41. doi: 10.1016/s0021-9673(00)86290-1. No abstract available.

Reference Type RESULT
PMID: 195970 (View on PubMed)

Geraedts J, Sermon K. Preimplantation genetic screening 2.0: the theory. Mol Hum Reprod. 2016 Aug;22(8):839-44. doi: 10.1093/molehr/gaw033. Epub 2016 Jun 2.

Reference Type RESULT
PMID: 27256482 (View on PubMed)

Balakier H, Sojecki A, Motamedi G, Librach C. Impact of multinucleated blastomeres on embryo developmental competence, morphokinetics, and aneuploidy. Fertil Steril. 2016 Sep 1;106(3):608-614.e2. doi: 10.1016/j.fertnstert.2016.04.041. Epub 2016 May 18.

Reference Type RESULT
PMID: 27206619 (View on PubMed)

Cimadomo D, Capalbo A, Ubaldi FM, Scarica C, Palagiano A, Canipari R, Rienzi L. The Impact of Biopsy on Human Embryo Developmental Potential during Preimplantation Genetic Diagnosis. Biomed Res Int. 2016;2016:7193075. doi: 10.1155/2016/7193075. Epub 2016 Jan 28.

Reference Type RESULT
PMID: 26942198 (View on PubMed)

Wang Z, Ang WT, Tan SY, Latt WT. Automatic segmentation of zona pellucida and its application in cleavage-stage embryo biopsy position selection. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3859-64. doi: 10.1109/EMBC.2015.7319236.

Reference Type RESULT
PMID: 26737136 (View on PubMed)

Dahdouh EM, Balayla J, Audibert F; Genetics Committee; Wilson RD, Audibert F, Brock JA, Campagnolo C, Carroll J, Chong K, Gagnon A, Johnson JA, MacDonald W, Okun N, Pastuck M, Vallee-Pouliot K. RETIRED: Technical Update: Preimplantation Genetic Diagnosis and Screening. J Obstet Gynaecol Can. 2015 May;37(5):451-63. doi: 10.1016/s1701-2163(15)30261-9.

Reference Type RESULT
PMID: 26168107 (View on PubMed)

Related Links

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0081962

Oct4/Sox2 Binding Sites Contribute to Maintaining Hypomethylation of the Maternal Igf2/H19 Imprinting Control Region

http://dx.doi.org/10.1016/S0092-8674(00)81769-9

Formation of Pluripotent Stem Cells in the Mammalian Embryo Depends on the POU Transcription Factor Oct4

http://www.ncbi.nlm.nih.gov/pubmed/12514105

Multipotent cell lineages in early mouse development depend on SOX2 function

Other Identifiers

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Embryo Biopsy

Identifier Type: -

Identifier Source: org_study_id

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