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

Ganin Fertility Center

Status: Completed

Conditions: Gender Ratio of ICSI Outcome

Treatments: Other: Density Gradient Centrifugation; Device: Magnetic Activated Cell Sorting; Device: Physiological ICSI

Study type: Observational

Funder types: Other

Identifiers

NCT03922568

GFC - 003

Details and patient eligibility

About

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

Full 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.

Enrollment: 388 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

388 participants in 3 patient groups

Density Gradient Centrifugation (DGC)

Description:

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

Treatment:

Other: Density Gradient Centrifugation

Physiological ICSI (PICSI)

Description:

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

Treatment:

Device: Physiological ICSI

Magnetic Activated Cell Sorting (MACS)

Description:

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.

Treatment:

Device: Magnetic Activated Cell Sorting