NCT04144621

Brief Summary

Retrospective cohort study for 189 couples assigned to normal and abnormal Sperm DNA fragmentation (SDF) groups.To determine the effect of SDF on blastocyst's trophectoderm (TE), Inner cell mass (ICM) morphology grading, and implantation rate. Semen in both groups was processed by density gradient (DG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

October 28, 2019

Last Update Submit

October 30, 2019

Conditions

BlastocystImplantation Rate

Keywords

Sperm DNA fragmentationImplantation ratePregnancy rateBlastocyst grading

Outcome Measures

Primary Outcomes (2)

  • Blastocyst morphological grading

    Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A to C ( A is the highest quality).

    5-6 days after ICSI

  • Implantation rate

    Percentage of the implanted embryos number for each group / number of transferred embryos.

    6 weeks of pregnancy

Secondary Outcomes (3)

  • Fertilization rate

    16-19 hours of ICSI

  • Blastulation rate

    5-6 days of ICSI

  • Pregnancy rate

    After 2 weeks of embryo transfer

Study Arms (2)

Normal SDF

Couples with male partners having SDF lower than 20% using TUNEL assay

Procedure: ICSI

Abnormal SDF

Couples with male partners having SDF greater than 20% using TUNEL assay

Procedure: ICSI

Interventions

ICSIPROCEDURE

Intracytoplasmic sperm injection of female partner oocytes with ejaculated sperm selected by density gradient centrifugation

Abnormal SDFNormal SDF

Eligibility Criteria

AgeUp to 37 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsfemale age ≤37 years old, with no limitation on male age
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

ICSI patients in Ganin Fertility Center from January 2018 to September 2018.

You may qualify if:

  • All cases in this study have to reach the blastocyst stage.
  • Female age ≤37 years old.
  • Male sperm count ≥ 5 million.

You may not qualify if:

  • Usage of sperm selection techniques.
  • Testicular aspiration or testicular biopsies.
  • Oocyte or sperm donation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganin Fertility Center

Cairo, 11728, Egypt

Location

Related Publications (3)

  • Wdowiak A, Bojar I. Relationship between pregnancy, embryo development, and sperm deoxyribonucleic acid fragmentation dynamics. Saudi J Biol Sci. 2016 Sep;23(5):598-606. doi: 10.1016/j.sjbs.2015.08.001. Epub 2015 Aug 10.

    PMID: 27579009BACKGROUND

  • Gat I, Tang K, Quach K, Kuznyetsov V, Antes R, Filice M, Zohni K, Librach C. Sperm DNA fragmentation index does not correlate with blastocyst aneuploidy or morphological grading. PLoS One. 2017 Jun 7;12(6):e0179002. doi: 10.1371/journal.pone.0179002. eCollection 2017.

    PMID: 28591199BACKGROUND

  • Alvarez Sedo C, Bilinski M, Lorenzi D, Uriondo H, Noblia F, Longobucco V, Lagar EV, Nodar F. Effect of sperm DNA fragmentation on embryo development: clinical and biological aspects. JBRA Assist Reprod. 2017 Dec 1;21(4):343-350. doi: 10.5935/1518-0557.20170061.

    PMID: 29116706BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

semen, oocytes, blastocysts

MeSH Terms

Interventions

Sperm Injections, Intracytoplasmic

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Manar Hozyen, MSc

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Eman Hassanen, BSc

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hosam Zaki, MSc, FRCOG

    Ganin Fertility Center

    STUDY CHAIR

  • Hanaa El Khedr

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Yasmine Azzouz, BSc

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

January 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

EG(1)