Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI

Sponsor
Ganin Fertility Center (Other)
Overall Status
Completed
CT.gov ID
NCT03922568
Collaborator
The Cleveland Clinic (Other), University of the Western Cape (Other)
388
1
31.9
12.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Density Gradient Centrifugation
  • Device: Physiological ICSI
  • Device: Magnetic Activated Cell Sorting

Detailed Description

A total of 529 babies of known gender born out of 388 ICSI cycles between August 2016 and May 2018 at Ganin Fertility Center, Cairo, Egypt, were investigated for the gender ratio and then divided into three groups according to the sperm selection technique used before performing sperm injection; DGC (237 neonates out of 173 ICSI cycles), PICSI (147 neonates out of 109 ICSI cycles) , and MACS (145 neonates out of 106 ICSI cycles). In PICSI and MACS groups. Power analysis was done by comparing the sex ratio of the neonates between DGC, PICSI and MACS. The chi-squared test for independent samples was chosen to perform the power analysis with α-error level at 0.05. P values less than 0.05 were considered statistically significant. All statistical calculations were done using IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows.

Study Design

Study Type:
Observational
Actual Enrollment :
388 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Mar 30, 2019
Actual Study Completion Date :
Mar 30, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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 Names:
  • DGC
  • 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
    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
    Other Names:
  • PICSI
  • 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
    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.
    Other Names:
  • MACS
  • Outcome Measures

    Primary Outcome Measures

    1. Gender ratio [36-40 weeks after ICSI]

      Neonatal gender ratio

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • Frozen sperm

    • Frozen Embryo transfer

    • Fresh cleavage stage embryo transfer

    • Vanishing Twin Syndrome

    • Fetal Reduction

    • Preimlantation genetically screened embryo transfer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ganin Fertility Center Cairo القاهرة Egypt 11728

    Sponsors and Collaborators

    • Ganin Fertility Center
    • The Cleveland Clinic
    • University of the Western Cape

    Investigators

    • Principal Investigator: 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
    • Study Director: Ralph Henkel, PhD, University of the Western Cape
    • Study Chair: Ashok Agarwal, PhD, American Center of Reproductive Medicine, Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    khaled Elqusi, Senior clinical embryologist, Ganin Fertility Center
    ClinicalTrials.gov Identifier:
    NCT03922568
    Other Study ID Numbers:
    • GFC - 003
    First Posted:
    Apr 22, 2019
    Last Update Posted:
    Apr 22, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by khaled Elqusi, Senior clinical embryologist, Ganin Fertility Center

    Study Results

    No Results Posted as of Apr 22, 2019