Clinical trial NCT04144621: Sperm DNA Fragmentation Effects on Blastocyst Morphology Grading, Pregnancy Rate and Implantation Rate
Official title: The Correlation of Sperm DNA Fragmentation With Blastocyst Grading and Its Implantation Potential
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blastocyst
Implantation Rate
Keywords: Sperm DNA fragmentation
Implantation rate
Pregnancy rate
Blastocyst grading
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 189
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICSI patients in Ganin Fertility Center from January 2018 to September 2018.

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).

Detailed description: Purpose: to determine if sperm DNA fragmentation (SDF) has a correlation with Blastocyst's trophectoderm (TE) and Inner cell mass (ICM) grading, or with the implantation rate?

Method: Retrospective cohort study for 189 couples, assigned to normal SDF group (121 cases), and abnormal SDF group (68 cases). Semen in both groups was processed by double layer density gradient (DG).

Statistical analysis done using SPSS version 22.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Blastocyst morphological grading
timeFrame: 5-6 days after ICSI
measure: Implantation rate
timeFrame: 6 weeks of pregnancy
Secondary outcomes:
measure: Fertilization rate
timeFrame: 16-19 hours of ICSI
measure: Blastulation rate
timeFrame: 5-6 days of ICSI
measure: Pregnancy rate
timeFrame: After 2 weeks of embryo transfer
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
Study officials:
affiliation: Ganin Fertility Center
name: Manar Hozyen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Eman Hassanen, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc, FRCOG
role: STUDY_CHAIR
affiliation: Ganin Fertility Center
name: Hanaa El Khedr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Yasmine Azzouz, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.