Side of Embryo Biopsy Interfering Implantation Potential

Preimplantation Diagnosis Clinical Trial

Official title:

Effect of Embryo Biopsy Side on Post Biopsy Blastocyst Structurs and Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902614
• Other study ID #: Embryo Biopsy
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2, 2018

Study information

• Verified date: January 2019
• Source: Al Baraka Fertility Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Preimplantation Diagnosis

Intervention

Procedure:
• Vegetal Pole blastomer embryo
for day 3 embryo biopsy / cleavage stage
• Animal Pole blastomer embryo
for day 3 embryo biopsy / cleavage stage

Locations

Country	Name	City	State
Bahrain	AHMAD Barakat	Manama
Egypt	Ibn Sina IVF Center- Ibn Sina Hospital	Sohag

Sponsors (2)

Lead Sponsor	Collaborator
Ahmad Mustafa Mohamed Metwalley	Ibn Sina Hospital

Countries where clinical trial is conducted

Bahrain,  Egypt, 

References & Publications (6)

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. — View Citation

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 — View Citation

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, Vallée-Pouliot K. Technical Update: Preimplantation Genetic Diagnosis and Scree — View Citation

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. Review. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blastocyst location of ICM at day 5	describing the location of the inner cell mass (ICM) in location to the zona peluceda (ZP) drilling opening.	2 months
Secondary	Implantation power	calculating the pregnancy rate for cases after biopsy.	2 months

External Links

•   Children born after preimplantation genetic diagnosis show no increase in congenital anomalies
•   Formation of Pluripotent Stem Cells in the Mammalian Embryo Depends on the POU Transcription Factor Oct4
•   Multipotent cell lineages in early mouse development depend on SOX2 function
•   Oct4 and Sox2 Directly Regulate Expression of Another Pluripotency Transcription Factor, Zfp206, in Embryonic Stem Cells
•   Oct4/Sox2 Binding Sites Contribute to Maintaining Hypomethylation of the Maternal Igf2/H19 Imprinting Control Region
•   Reprogramming with defined factors: from induced pluripotency to induced transdifferentiation