DGC/Zeta as A New Strategy to Improve Clinical Outcome in Male Factor Infertility Patients following Intracytoplasmic Sperm Injection: A Randomized, Single-Blind, Clinical Trial


Nazanin Karimi, M.Sc, 1Homa Mohseni Kouchesfahani, Ph.D, 1,*Mohammad Hossein Nasr-Esfahani, Ph.D, 2,*Marziyeh Tavalaee, Ph.D., 2Abdolhossein Shahverdi, Ph.D., 3,4Hamid Choobineh, Ph.D., 5
Department of Animal Biology, Faculty of Biological Sciences, Kharazmi University, Tehran, Iran
Department of Reproductive Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran
Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Department of Embryology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
School of Allied Medical Science, Tehran University of Medical Sciences, Tehran, Iran
Department of Animal Biology, Faculty of Biological Sciences, Kharazmi University, Tehran, Iran
Department of Reproductive Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran
Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Department of Embryology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
School of Allied Medical Science, Tehran University of Medical Sciences, Tehran, Iran
*Corresponding Addresses: P.O. Box: 15815/3587 Department of Animal Biology Faculty of Biological Sciences Kharazmi University Tehran Iran P.O.Box: 8165131378 Department of Reproductive Biotechnology Reproductive Biomedicine Research Center Royan Institute for Biotechnology ACECR Isfahan Iran Emails:kouchesfehani@khu.ac.ir,mh.nasr-esfahani@royaninstitute.org
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Abstract

Objective

The aim of this blind randomised clinical trial study was to assess the clinical efficiency of combined density gradient centrifugation/Zeta (DGC/Zeta) sperm selection procedure compared to conventional DGC in infertile men candidates for intracytoplasmic sperm injection (ICSI). The literature shows that DGC/Zeta is more effective compared to DGC alone in selection of sperms with normal chromatin and improves the clinical outcome of the ICSI procedure. Therefore, this study re-evaluates the efficiency of DGC/Zeta in improving the clinical outcomes of ICSI in an independent clinical setting.

Materials and Methods

In this randomized, single-blind, clinical trial, a total of 240 couples with male factor infertility and at least one abnormal sperm parameter were informed regarding the study and 220 participated. Based on inclusion and exclusion criteria, 103 and 102 couples were randomly allocated into the DGC/Zeta and DGC groups, respectively. ICSI outcomes were followed and compared between the two groups.

Results

Although there was no significant difference in fertilization rate (P=0.67) between the DGC/Zeta and DGC groups, mean percentage of good embryo quality (P=0.04), good blastocysts quality (P=0.049), expanded blastocysts (P=0.007), chemical pregnancies (P=0.005) and clinical pregnancies (P=0.007) were significantly higher in the DGC/ Zeta group compared to DGC. In addition, implantation rate was insignificantly higher in DGC/Zeta compared to DGC (P=0.17).

Conclusion

This is the second independent study showing combined DGC/Zeta procedure improves ICSI outcomes, especially the pregnancy rate, compared to the classical DGC procedure and this is likely related to the improved quality of sperm selected by the DGC/Zeta procedure (Registration number: IRCT20180628040270N1).