Management of Abnormally Fertilized Zygotes? InVitro Correction of 3PN
NCT ID: NCT02358759
Last Updated: 2016-01-12
Study Results
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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COMPLETED
EARLY_PHASE1
22 participants
INTERVENTIONAL
2014-06-30
2015-09-30
Brief Summary
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The investigators developed the plan and requirements needed to select the target extra nucleus or pronuclei to be extruded from fertilized egg in order to maintain developing healthy normal embryo.
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Detailed Description
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One of Digynic triploidy is developed by fertilized giant oocyte (Dyban and Baranov, 1987) {nuclear but no cytoplasmic division in an oogonium or cytoplasmic fusion of two oogonia (Austin, 1960)}.
Giant oocyte characterized with bigger diameter and will distinguished polar bodies at metaphase II.
B. Rosenbusch et. al. 2002, cytogenetic study showed that extra haploid maternal copy associated with MII (46,XX/ 2N ) giant oocytes as well as triploidy with fertilized giant oocytes (3N with 69,XXX or 69,XXY).
First Mitotic division plane with polar axes studies by Scott, 2001 , shows that Pn developed closer to 2nd polar body is the maternal origin PN.
Giant oocytes were collected from different IVF cycles, to be injected with normal sperm using Intracytoplasmic sperm injection (ICSI). 18 hours post ICSI arranged for fertilization evaluation and PN removal for fertilized oocyte before syngamy starts.
Video attached shows process of zygote manipulation by the way avoiding the division axis and focusing the extra maternal PN to be aspirated.
Pronuclear transfer in human embryos for mitochondrial DNA correction started the methodology of pronuclear manipulation, for that possibility of utilizing of 3PNs developed embryos research tools can be started. We arranged to study available received giant oocytes during IVF cycles. Accordingly we arranged for pronuclear removal followed by FISH evaluation in order to targeting Normal males embryos that insure proper extra maternal pronucleus removal.
Successful trials of maternal PN removal for giant oocyte collected from different cases summarized in table 1. All blastocyst developed arranged for FISH, so all embryos were utilized for cytogenetic evaluation.
Recommendations:
Further evaluations using STRs (Short tandem repeat ) should be used for maternal-paternal genome differentiation. NGS study is under evaluation for developed embryos for full CCS reporting and more genetic integrity. Epigenetic evaluation study recommended for triploidy corrected embryos for genetic expressions and early embryo developments as well as differentiation between paternal and maternal genomic activity.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Giant Oocytes after ICSI
abnormally produced oocyte after ART or Controlled ovarian stimulation. Correction of abnormally fertilized oocytes using nucleus removal.
Correction of abnormally fertilized oocytes
Removing of extra developed nucleus from fertilized oocyte.
3PNs zygotes developed after ICSI
Abnormally developed embryos these produced 3PNs. Correction of abnormally fertilized oocytes using nucleus removal.
Correction of abnormally fertilized oocytes
Removing of extra developed nucleus from fertilized oocyte.
Interventions
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Correction of abnormally fertilized oocytes
Removing of extra developed nucleus from fertilized oocyte.
Eligibility Criteria
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Inclusion Criteria
* 3 PNs developed embryos at day 1 post ICSI.
Exclusion Criteria
20 Years
45 Years
ALL
No
Sponsors
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Ahmad Mustafa Mohamed Metwalley
OTHER
Responsible Party
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Ahmad Mustafa Mohamed Metwalley
IVF unit director
Principal Investigators
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Ahmad M Metwalley
Role: PRINCIPAL_INVESTIGATOR
Al Baraka Fertility Hospital
Locations
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Al Baraka Fertility Hospital
Manama, Adliyah, Bahrain
Ibn Sina IVF Center- Ibn Sina Hospital
Sohag, Sohag Governorate, Egypt
Countries
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References
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Jacobs PA, Angell RR, Buchanan IM, Hassold TJ, Matsuyama AM, Manuel B. The origin of human triploids. Ann Hum Genet. 1978 Jul;42(1):49-57. doi: 10.1111/j.1469-1809.1978.tb00930.x.
Rosenbusch B. The potential significance of binovular follicles and binucleate giant oocytes for the development of genetic abnormalities. J Genet. 2012;91(3):397-404. doi: 10.1007/s12041-012-0195-x.
Wolf DP, Mitalipov N, Mitalipov S. Mitochondrial replacement therapy in reproductive medicine. Trends Mol Med. 2015 Feb;21(2):68-76. doi: 10.1016/j.molmed.2014.12.001. Epub 2014 Dec 10.
Vogel G. Assisted reproduction. FDA considers trials of 'three-parent embryos'. Science. 2014 Feb 21;343(6173):827-8. doi: 10.1126/science.343.6173.827. No abstract available.
Amato P, Tachibana M, Sparman M, Mitalipov S. Three-parent in vitro fertilization: gene replacement for the prevention of inherited mitochondrial diseases. Fertil Steril. 2014 Jan;101(1):31-5. doi: 10.1016/j.fertnstert.2013.11.030.
Other Identifiers
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AlBarakaSD3
Identifier Type: -
Identifier Source: org_study_id
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