Gender Ratio of ICSI OutcomeNCT03922568
Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI
An observational study of Gender Ratio of ICSI Outcome, run by Ganin Fertility Center at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gender Ratio of ICSI Outcome
- What is being tested?
- Density Gradient Centrifugation, Physiological ICSI and Magnetic Activated Cell Sorting
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 388 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2016to 30 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases undergoing ICSI in Ganin Fertility Center
Who may be able to join
- 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
Who cannot join
- Frozen sperm
- Frozen Embryo transfer
- Fresh cleavage stage embryo transfer
- Vanishing Twin Syndrome
- Fetal Reduction
- Preimlantation genetically screened embryo transfer
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Density Gradient Centrifugation, Physiological ICSI, Magnetic Activated Cell Sorting
- Keywords
- Gender Ratio, PICSI, MACS, Sperm Selection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Density Gradient CentrifugationOther
Also called 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
Physiological ICSIDevice
Also called PICSI
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
Magnetic Activated Cell SortingDevice
Also called MACS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Density Gradient Centrifugation | |
| 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 Receives: Device: Physiological ICSI | |
| 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. Receives: Device: Magnetic Activated Cell Sorting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender ratio
Neonatal gender ratio
Measured: 36-40 weeks after ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Aug 2016
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gender Ratio of ICSI OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, University of the Western Cape
- Responsible party
- Principal investigator, khaled Elqusi, Ganin Fertility Center
- Investigators
- khaled Elqusi, BSc, Principal investigator, Ganin Fertility CenterEman Hassanen, Bsc, Principal investigator, Ganin Fertility CenterHanaa Alkhader, ABB( ELD), Principal investigator, Ganin Fertility CenterHosam Zaki, MSc, FRCOG, Principal investigator, Ganin Fertility CenterRalph Henkel, PhD, Study director, University of the Western CapeAshok Agarwal, PhD, Study chair, American Center of Reproductive Medicine, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922568
- Sponsor's protocol ID
- GFC - 003
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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. doi: 10.1093/humrep/deh361. Epub 2004 Jun 17.
PubMed 15205404Avendano 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.
PubMed 18440529Said 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.
PubMed 21873262McElreavey K, Krausz C. Sex Chromosome Genetics '99. Male infertility and the Y chromosome. Am J Hum Genet. 1999 Apr;64(4):928-33. doi: 10.1086/302351. No abstract available.
PubMed 10090876Niederberger C. Absence of de novo Y-chromosome microdeletions in male children conceived through intracytoplasmic sperm injection. J Urol. 2005 Sep;174(3):1046. doi: 10.1097/01.ju.0000171902.28215.84. No abstract available.
PubMed 16094051Komori 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. doi: 10.1007/s100380200066.
PubMed 12202984Palermo 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.
PubMed 1351601
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sperm Selection Techniques on Human Neonatal Gender Ratio in Patients Undergoing ICSI
- ClinicalTrials.gov ID
- NCT03922568
- Acronym / sponsor ID
- GFC - 003
- Conditions
- Gender Ratio of ICSI Outcome
- Keywords
- Gender Ratio, PICSI, MACS, Sperm Selection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, University of the Western Cape
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Density Gradient Centrifugation (DGC) | – | Other: Density Gradient Centrifugationsemen 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 |
| Physiological ICSI (PICSI) | – | Device: Physiological ICSISemen 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 |
| Magnetic Activated Cell Sorting (MACS) | – | Device: Magnetic Activated Cell SortingSemen 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases undergoing ICSI in Ganin Fertility Center
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Frozen sperm
- Frozen Embryo transfer
- Fresh cleavage stage embryo transfer
- Vanishing Twin Syndrome
- Fetal Reduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Density Gradient CentrifugationAlso: DGCsemen 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 (DGC) |
| Physiological ICSIAlso: PICSISemen 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 | Physiological ICSI (PICSI) |
| Magnetic Activated Cell SortingAlso: MACSSemen 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. | Device | Magnetic Activated Cell Sorting (MACS) |
Primary outcome
Gender ratio
Time frame: 36-40 weeks after ICSI
Neonatal gender ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Background: PubMed 15205404Celik-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. doi: 10.1093/humrep/deh361. Epub 2004 Jun 17.
- Background: PubMed 18440529Avendano 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.
- Background: PubMed 21873262Said 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.
- Background: PubMed 10090876McElreavey K, Krausz C. Sex Chromosome Genetics '99. Male infertility and the Y chromosome. Am J Hum Genet. 1999 Apr;64(4):928-33. doi: 10.1086/302351. No abstract available.
- Background: PubMed 16094051Niederberger C. Absence of de novo Y-chromosome microdeletions in male children conceived through intracytoplasmic sperm injection. J Urol. 2005 Sep;174(3):1046. doi: 10.1097/01.ju.0000171902.28215.84. No abstract available.
- Background: PubMed 12202984Komori 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. doi: 10.1007/s100380200066.
- Results publication: PubMed 1351601Palermo 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
khaled Elqusi, BSc principal investigator
Ganin Fertility Center
Eman Hassanen, Bsc principal investigator
Ganin Fertility Center
Hanaa Alkhader, ABB( ELD) principal investigator
Ganin Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Ratio of ICSI Outcome, run by Ganin Fertility Center at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender ratio (time frame: 36-40 weeks after ICSI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922568, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.