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

• ClinicalTrials.gov Identifier: NCT03922568
• Recruitment Status: Completed
• First Posted: April 22, 2019
• Last Update Posted: April 22, 2019
• Sponsor: Ganin Fertility Center
• Collaborators: The Cleveland Clinic; University of the Western Cape
• Information provided by (Responsible Party): khaled Elqusi, Ganin Fertility Center

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
Gender Ratio of ICSI Outcome	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: August 1, 2016
• Actual Primary Completion Date: March 30, 2019
• Actual Study Completion Date: March 30, 2019

Groups and Cohorts

Group/Cohort	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 Name: 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 Name: 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 Name: MACS

Outcome Measures

Primary Outcome Measures :

1. Gender ratio [ Time Frame: 36-40 weeks after ICSI ]
   Neonatal gender ratio

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Cases undergoing ICSI in Ganin Fertility Center

Criteria

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

Egypt

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

More Information

Publications of Results:

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.

Other Publications:

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. Epub 2004 Jun 17.

Avendaño 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.

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. Review.

McElreavey K, Krausz C. Sex Chromosome Genetics '99. Male infertility and the Y chromosome. Am J Hum Genet. 1999 Apr;64(4):928-33. Review.

Niederberger C. Absence of de novo Y-chromosome microdeletions in male children conceived through intracytoplasmic sperm injection. J Urol. 2005 Sep;174(3):1046.

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.

• Responsible Party: khaled Elqusi, Senior clinical embryologist, Ganin Fertility Center
• ClinicalTrials.gov Identifier: NCT03922568
• Other Study ID Numbers: GFC - 003
• First Posted: April 22, 2019
• Last Update Posted: April 22, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• 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, Ganin Fertility Center:

Gender Ratio; PICSI; MACS; Sperm Selection