What is the Best Sperm Source and Way of Sperm Selection in Cases With Abnormal sORP Levels on the Day of ICSI?

What is the Best Sperm Source and Way of Sperm Selection in Cases With Abnormal Static Oxidation Reduction Potential (sORP) Levels on the Day of ICSI?

Does the level of statistic oxidation reduction potential (sORP) affects the choice of sperm source or sperm selection method used during ICSI.

Study Overview

• Status: Unknown
• Conditions: Oxidative Stress
• Intervention / Treatment: Device: PICSI; Procedure: TESA

Detailed Description

Reactive oxygen species (ROS) are an integral component of sperm developmental physiology, capacitation, and function. Elevated ROS levels, from processes such as infection or inflammation, can be associated with male infertility and also decreases the overall ICSI success rates[1][2]

Several techniques are available for measuring ROS, but only Mioxsys can measure the imbalance between production of reactive oxygen species (ROS) and activity of the antioxidant defense system in semen in terms of sORP. Mioxsys is a robust test that gives the result in a very short time, so it became applicable to test sORP on day of ICSI [2]

Injection with sperm selected by PICSI dishes or testicular sperm aspiration (TESA) is thought to decrease or eliminate the unwanted ROS but none of them was reported to be more efficient than the other with regards to the clinical outcomes.

A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zona pellucida, could improve the likelihood of obtaining better sperm for ICSI. It is thought that excessive ROS damages sperm membranes, reduces sperm motility, and induces sperm DNA damage [3]

The topographic assessment of sperm chromatin integrity throughout the male genital tract suggested that there is a disruption in DNA packing during spermiogenesis that does not allow sperm chromatin to withstand oxidative stressors, possibly compounded by a compromised total antioxidant capacity in the seminal fluid [4]. The utilization of testicular spermatozoa may represent a viable option for men with high ROS level in their ejaculates.

• Study Type: Interventional
• Enrollment (Anticipated): 820
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hosam Zaki, MSc, FRCOG; Phone Number: +201222150018; Email: hosamz@tedata.net.eg
• Study Contact Backup: Name: Eman Hasanen, BSc; Phone Number: +201282012291; Email: em.saberh@gmail.com

Study Locations

• Egypt
  • Cairo
    • Maadi, Cairo, Egypt, 12345
      • Recruiting
      • Ganin Fertility Center
      • Contact: Eman Hasanen, BSc; Phone Number: 00201282012291; Email: em.saberh@gmail.com
      • Contact: Hosam Zaki, MD; Phone Number: 00201222150018; Email: hosamz@tedata.net.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Diagnosed of abnormal male semen parameters such as abnormal sperm parameters according to WHO 2010 or high DNA fragmentation using TUNEL as a cause of couple infertility.
• Abnormal sORP level on the day of ICSI.
• Males with mild OTA (oligoteratoasthenozoospermia).
• Female aged 18-35 years.
• Normo responder ( > 8 mature oocytes)
• Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of oocyte retrieval

Exclusion Criteria:

• Normal Semen fluid analysis ( WHO 2010) during the initial assessment of the male
• Normal sORP levelat the day of ICSI
• 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 previously known uterine infection
• Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PICSI; Physiological ICSI	Device: PICSI; Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. (Selecting an individual bound sperm with enhanced genetic and developmental integrity ensures that the sperm selected is the optimal sperm from the sample for oocyte injection.
Experimental: TESA; Testicular sperm aspiration	Procedure: TESA; Patients will undergo TESA which is performed by sticking a needle in the testis and aspirating fluid and tissue with negative pressure then examine the sample for presence of motile sperms followed by sample processing and oocyte injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy rate	Defined as the proportion of pregnancies that had completed ≥20 weeks of gestation.	20 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cleavage rate	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes	3 days
Blastulation rate	Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3	5-6 days
Fertilization rate	Defined as the proportion of 2PNs formed over the injected oocytes	16-18 hours
Blastocyst quality rate	Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or bad in terms of percentage of the total formed blastocysts	5-6 days
Pregnancy rate	Defined as clinical pregnancy per embryo(s) 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(s) transferred.	6- 8 weeks following embryo transfer]

Collaborators and Investigators

• Sponsor: Ganin Fertility Center
• Collaborators: The Cleveland Clinic; University of the Western Cape
• Investigators: Study Chair: Hosam Zaki, MSc, FRCOG, Ganin Fertility Center, Cairo, Egypt; Principal Investigator: Eman Hasanen, BSc, Ganin Fertility Center, Cairo, Egypt; Principal Investigator: Ralph Henkel, PhD, University of the Western Cape; Principal Investigator: Khaled Elqusi, BSc, Ganin Fertility Center, Cairo, Egypt; Study Director: Ashok Agarwal, Ph.D, American Center of reproductive medicine, Cleveland Clinic, Ohio, USA; Principal Investigator: Hanaa Elkhedr, ABB( ELD), Ganin Fertility Center, Cairo, Egypt

Publications and helpful links

General Publications

• Agarwal A, Sharma R, Roychoudhury S, Du Plessis S, Sabanegh E. MiOXSYS: a novel method of measuring oxidation reduction potential in semen and seminal plasma. Fertil Steril. 2016 Sep 1;106(3):566-573.e10. doi: 10.1016/j.fertnstert.2016.05.013. Epub 2016 May 31.
• Agarwal A, Roychoudhury S, Sharma R, Gupta S, Majzoub A, Sabanegh E. Diagnostic application of oxidation-reduction potential assay for measurement of oxidative stress: clinical utility in male factor infertility. Reprod Biomed Online. 2017 Jan;34(1):48-57. doi: 10.1016/j.rbmo.2016.10.008. Epub 2016 Oct 20.
• Natali A, Turek PJ. An assessment of new sperm tests for male infertility. Urology. 2011 May;77(5):1027-34. doi: 10.1016/j.urology.2010.10.005. Epub 2011 Jan 22.
• T. Cozzubbo, Q.V. Neri, M. Goldstein, Z. Rosenwaks, G.D. Palermo. Topographic mapping of sperm DNA fragmentation within the male genital tract.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: PICSI; TESA; ORP; seminal oxidation reduction potential
• Other Study ID Numbers: EMSH25390

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No