Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.

July 21, 2020 updated by: Ganin Fertility Center

Reproductive Outcomes of Different Sperm Selection Techniques; Density Gradient Centrifugation, Testicular Sperm, PICSI, and MACS for ICSI Patients With Abnormal Sperm DNA Fragmentation

Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

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
    • Maadi
      • Cairo, Maadi, Egypt, 1728
        • 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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female age was ≤37 years
  • Female should has 5≥ metaphase II oocytes
  • Males having abnormal SDF levels ≥ 20.3% by TUNEL assay
  • Abstinence from 1 to 2 days
  • Males having at least 1 million total motile progressive count

Exclusion Criteria:

  • Leukocytospermia
  • Presence of varicocele.
  • Known genetic abnormality
  • Use of sperm donation or cryopreserved sperm
  • Use of Oocyte donation
  • Use of gestational carrier
  • Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
  • Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Density Gradient Centrifugation (DGC)
Using the routine DGC sperm processing only
Other: Density Gradient Centrifugation
Semen processing is done by double layer density gradient method.
Other Names:
  • DGC
Active Comparator: Physiological ICSI (PICSI)
Using PICSI dish for selecting sperm with lower sperm DNA fragmentation
Other: Physiological ICSI
Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head
Other Names:
  • PICSI
Active Comparator: Magnetic Activated Cell Sorting (MACS)
Using MACS for selecting sperm with lower sperm DNA fragmentation
Other: Magnetic activated cell sorting
Sperm selection by using Annexin V micro-beads and separation columns
Other Names:
  • MACS
Active Comparator: Testicular sperm (Testi)
Using testicular sperm not ejaculated sperm
Other: Testicular sperm
Using testicular sperm retrieved by TESA or TESE
Other Names:
  • Testi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 14 days following embryo transfer
Defined as clinical pregnancy per transfer
14 days following embryo transfer
Implantation rate
Time Frame: 6- 8 weeks following embryo transfer
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
6- 8 weeks following embryo transfer
Ongoing pregnancy rate
Time Frame: 20 weeks of gestation
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
20 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cleavage rate
Time Frame: 3 days
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes
3 days
Blastulation rate
Time Frame: 5-6 days
Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3
5-6 days
High quality blastocyst rate
Time Frame: 5-6 days
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or bad in terms of percentage of the total formed blastocysts
5-6 days
Miscarriage rate
Time Frame: 20 weeks of gestation
Defined as the proportion of miscarried cases
20 weeks of gestation

Collaborators and Investigators

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

Sponsor

Ganin Fertility Center

Investigators

  • Principal Investigator: Eman Hasanen, Ganin Fertility Center
  • Principal Investigator: khaled Elqusi, Ganin Fertility Center
  • Principal Investigator: Salma Eltanbouly, Ganin Fertility Center
  • Principal Investigator: Samar Gamal, Ganin Fertility Center
  • Principal Investigator: Abd ElGhafar Hussin, Ganin Fertility Center
  • Principal Investigator: Hanaa Elkhadr, Ganin Fertility Center

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)

March 1, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 18, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH-005

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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