NCT03922568

Brief Summary

babies of known gender born out of 388 ICSI cycles were investigated for the gender ratio and then divided into three groups according to the sperm selection technique used before performing sperm injection. Statistical analysis were made to compare ratios and compare results of three arms

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

April 17, 2019

Last Update Submit

April 17, 2019

Conditions

Gender Ratio of ICSI Outcome

Keywords

Gender RatioPICSIMACSSperm Selection

Outcome Measures

Primary Outcomes (1)

  • Gender ratio

    Neonatal gender ratio

    36-40 weeks after ICSI

Study Arms (3)

Density Gradient Centrifugation (DGC)

semen was layered over 50 % and 90% discontinuous Density Gradient layers in a 15ml conical tube, then centrifuged at 250 g for 8 min at room temperature. supernatant was aspirated and the resulted pellet was washed using Sperm wash media and centrifuged at 250 g for 8 min at room temperature. The final pellet was re suspended in residual volume

Other: Density Gradient Centrifugation

Physiological ICSI (PICSI)

Semen processing is done by double layer DGC method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Hyaluronan bound sperms are selected for oocyte injection

Device: Physiological ICSI

Magnetic Activated Cell Sorting (MACS)

Semen processing is done by double layer DGC method. The resulted pellet is labeled with Annexin V microbeads followed by separation on MACS column, the eluted fraction contains non apoptotic sperms suitable for oocyte injection.

Device: Magnetic Activated Cell Sorting

Interventions

Density Gradient CentrifugationOTHER

semen was layered over 50 % and 90% discontinuous Density Gradient layers in a 15ml conical tube, then centrifuged at 250 g for 8 min at room temperature. supernatant was aspirated and the resulted pellet was washed using Sperm wash media and centrifuged at 250 g for 8 min at room temperature. The final pellet was re suspended in residual volume

Also known as: DGC
Density Gradient Centrifugation (DGC)
Physiological ICSIDEVICE

Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Hyaluronan bound sperms are selected for oocyte injection

Also known as: PICSI
Physiological ICSI (PICSI)
Magnetic Activated Cell SortingDEVICE

Semen processing is done by double layer density gradient method. The resulted pellet is labeled with Annexin V microbeads followed by separation on MACS column, the eluted fraction contains non apoptotic sperms suitable for oocyte injection.

Also known as: MACS
Magnetic Activated Cell Sorting (MACS)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cases undergoing ICSI in Ganin Fertility Center

You may qualify if:

  • Full Term Delivery
  • ICSI cases using DGC for sperm selection
  • ICSI cases using MACS for sperm selection
  • ICSI cases using PICSI dishes for sperm selection
  • Fresh blastocyst stage embryo transfer at
  • Fresh ejaculate

You may not qualify if:

  • Frozen sperm
  • Frozen Embryo transfer
  • Fresh cleavage stage embryo transfer
  • Vanishing Twin Syndrome
  • Fetal Reduction
  • Preimlantation genetically screened embryo transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganin Fertility Center

Cairo, Cairo Governorate, 11728, Egypt

Location

Related Publications (7)

  • Celik-Ozenci C, Jakab A, Kovacs T, Catalanotti J, Demir R, Bray-Ward P, Ward D, Huszar G. Sperm selection for ICSI: shape properties do not predict the absence or presence of numerical chromosomal aberrations. Hum Reprod. 2004 Sep;19(9):2052-9. doi: 10.1093/humrep/deh361. Epub 2004 Jun 17.

    PMID: 15205404BACKGROUND

  • Avendano C, Franchi A, Taylor S, Morshedi M, Bocca S, Oehninger S. Fragmentation of DNA in morphologically normal human spermatozoa. Fertil Steril. 2009 Apr;91(4):1077-84. doi: 10.1016/j.fertnstert.2008.01.015. Epub 2008 Apr 28.

    PMID: 18440529BACKGROUND

  • Said TM, Land JA. Effects of advanced selection methods on sperm quality and ART outcome: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):719-33. doi: 10.1093/humupd/dmr032. Epub 2011 Aug 25.

    PMID: 21873262BACKGROUND

  • McElreavey K, Krausz C. Sex Chromosome Genetics '99. Male infertility and the Y chromosome. Am J Hum Genet. 1999 Apr;64(4):928-33. doi: 10.1086/302351. No abstract available.

    PMID: 10090876BACKGROUND

  • Niederberger C. Absence of de novo Y-chromosome microdeletions in male children conceived through intracytoplasmic sperm injection. J Urol. 2005 Sep;174(3):1046. doi: 10.1097/01.ju.0000171902.28215.84. No abstract available.

    PMID: 16094051BACKGROUND

  • Komori S, Kato H, Kobayashi S, Koyama K, Isojima S. Transmission of Y chromosomal microdeletions from father to son through intracytoplasmic sperm injection. J Hum Genet. 2002;47(9):465-8. doi: 10.1007/s100380200066.

    PMID: 12202984BACKGROUND

  • Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.

    PMID: 1351601RESULT

MeSH Terms

Interventions

Centrifugation, Density Gradient

Intervention Hierarchy (Ancestors)

UltracentrifugationCentrifugationInvestigative TechniquesChemistry Techniques, Analytical

Study Officials

  • khaled Elqusi, BSc

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Eman Hassanen, Bsc

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hanaa Alkhader, ABB( ELD)

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hosam Zaki, MSc, FRCOG

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Ralph Henkel, PhD

    University of the Western Cape

    STUDY DIRECTOR

  • Ashok Agarwal, PhD

    American Center of Reproductive Medicine, Cleveland Clinic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior clinical embryologist

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

August 1, 2016

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

EG(1)