NCT03922568

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 388 (actual)
• Sponsor: Ganin Fertility Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

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.

Conditions

• Gender Ratio of ICSI Outcome

Interventions

Type	Name	Description
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
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
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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-03-30
• Completion: 2019-03-30
• First posted: 2019-04-22
• Last updated: 2019-04-22

Locations

1 site across 1 country: Egypt