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

April 17, 2019 updated by: khaled Elqusi, Ganin Fertility Center
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • القاهرة
      • Cairo, القاهرة, Egypt, 11728
        • Ganin Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases undergoing ICSI in Ganin Fertility Center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • MACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender ratio
Time Frame: 36-40 weeks after ICSI
Neonatal gender ratio
36-40 weeks after ICSI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ganin Fertility Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

March 30, 2019

Study Completion (Actual)

March 30, 2019

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GFC - 003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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