NCT04482517

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

1.8 years

First QC Date

July 18, 2020

Last Update Submit

July 21, 2020

Conditions

Infertility, Male

Keywords

Sperm DNA fragmentationPICSIMACSSperm SelectionDGC

Outcome Measures

Primary Outcomes (3)

  • Clinical pregnancy rate

    Defined as clinical pregnancy per transfer

    14 days following embryo transfer

  • Implantation rate

    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

    Defined as the proportion of pregnancies that completed more than 20 weeks of gestation

    20 weeks of gestation

Secondary Outcomes (4)

  • Cleavage rate

    3 days

  • Blastulation rate

    5-6 days

  • High quality blastocyst rate

    5-6 days

  • Miscarriage rate

    20 weeks of gestation

Study Arms (4)

Density Gradient Centrifugation (DGC)

OTHER

Using the routine DGC sperm processing only

Other: Density Gradient Centrifugation

Physiological ICSI (PICSI)

ACTIVE COMPARATOR

Using PICSI dish for selecting sperm with lower sperm DNA fragmentation

Other: Physiological ICSI

Magnetic Activated Cell Sorting (MACS)

ACTIVE COMPARATOR

Using MACS for selecting sperm with lower sperm DNA fragmentation

Other: Magnetic activated cell sorting

Testicular sperm (Testi)

ACTIVE COMPARATOR

Using testicular sperm not ejaculated sperm

Other: Testicular sperm

Interventions

Density Gradient CentrifugationOTHER

Semen processing is done by double layer density gradient method.

Also known as: DGC
Density Gradient Centrifugation (DGC)
Physiological ICSIOTHER

Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head

Also known as: PICSI
Physiological ICSI (PICSI)
Magnetic activated cell sortingOTHER

Sperm selection by using Annexin V micro-beads and separation columns

Also known as: MACS
Magnetic Activated Cell Sorting (MACS)
Testicular spermOTHER

Using testicular sperm retrieved by TESA or TESE

Also known as: Testi
Testicular sperm (Testi)

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganin Fertility Center

Cairo, Maadi, 1728, Egypt

Location

Related Publications (1)

  • Hozyen M, Hasanen E, Elqusi K, ElTanbouly S, Gamal S, Hussin AG, AlKhader H, Zaki H. Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients with Abnormal Sperm DNA Fragmentation: a Randomized Controlled Trial. Reprod Sci. 2022 Jan;29(1):220-228. doi: 10.1007/s43032-021-00642-y. Epub 2021 Jun 2.

    PMID: 34076869DERIVED

MeSH Terms

Conditions

Infertility, Male

Interventions

Centrifugation, Density GradientSperm Retrieval

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

UltracentrifugationCentrifugationInvestigative TechniquesChemistry Techniques, AnalyticalReproductive Techniques, AssistedReproductive TechniquesTherapeuticsTissue and Organ HarvestingTransplantationSurgical Procedures, Operative

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Hosam Zaki

    Ganin Fertility Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2020

First Posted

July 22, 2020

Study Start

March 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

EG(1)