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OpenTrials
Completed

NCT Number: NCT03922568

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

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

Completed

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Key information

Conditions

Gender Ratio of ICSI Outcome

Sex eligibility

All sexes

Study type

Observational

Primary location

Ganin Fertility Center

Cairo, Cairo Governorate, 11728, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Density Gradient Centrifugation

Other

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

Device

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

Device

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

Primary outcomes

  1. Gender ratio

    Time frame: 36-40 weeks after ICSI

    Neonatal gender ratio

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Collaborators

  • The Cleveland Clinic
  • University of the Western Cape

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2019
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.