Sperm DNA Fragmentation Effects on Blastocyst Morphology Grading, Pregnancy Rate and Implantation Rate

Blastocyst Clinical Trial

Official title:

The Correlation of Sperm DNA Fragmentation With Blastocyst Grading and Its Implantation Potential

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144621
• Other study ID #: MH0001
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2019
• Source: Ganin Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Gender: All
• Age group: N/A to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blastocyst
• Implantation Rate

Intervention

Procedure:
• ICSI
Intracytoplasmic sperm injection of female partner oocytes with ejaculated sperm selected by density gradient centrifugation

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Alvarez Sedó C, Bilinski M, Lorenzi D, Uriondo H, Noblía 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Implantation rate	Percentage of the implanted embryos number for each group / number of transferred embryos.	6 weeks of pregnancy
Secondary	Fertilization rate	Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes	16-19 hours of ICSI
Secondary	Blastulation rate	Percentage of total blastocysts / total 2PN	5-6 days of ICSI
Secondary	Pregnancy rate	Percentage of pregnant cases / transferred cases for each group ( positive pregnancy test)	After 2 weeks of embryo transfer