Clinical trial NCT03922568: Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI
Official title: Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender Ratio of ICSI Outcome
Keywords: Gender Ratio
PICSI
MACS
Sperm Selection
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: University of the Western Cape
First posted: 2019-04-22
Enrollment: 388
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases undergoing ICSI in Ganin Fertility Center

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

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.

Eligibility 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

Primary outcomes:
measure: Gender ratio
timeFrame: 36-40 weeks after ICSI
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
state: القاهرة
Study officials:
affiliation: Ganin Fertility Center
name: khaled Elqusi, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Eman Hassanen, Bsc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hanaa Alkhader, ABB( ELD)
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc, FRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the Western Cape
name: Ralph Henkel, PhD
role: STUDY_DIRECTOR
affiliation: American Center of Reproductive Medicine, Cleveland Clinic
name: Ashok Agarwal, PhD
role: STUDY_CHAIR
References:
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citation: Avendano 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.
citation: 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.
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citation: 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. doi: 10.1016/0140-6736(92)92425-f.