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

Oxidative Stress Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360526
• Other study ID #: EMSH25390
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: Ganin Fertility Center
• Contact: Hosam Zaki, MSc, FRCOG
• Phone: +201222150018
• Email: hosamz[@]tedata.net.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 820
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

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.

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.

Locations

Country	Name	City	State
Egypt	Ganin Fertility center	Maadi	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Ganin Fertility Center	The Cleveland Clinic, University of the Western Cape

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

T. Cozzubbo, Q.V. Neri, M. Goldstein, Z. Rosenwaks, G.D. Palermo. Topographic mapping of sperm DNA fragmentation within the male genital tract.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Defined as the proportion of pregnancies that had completed =20 weeks of gestation.	20 weeks of gestation
Secondary	Fertilization rate	Defined as the proportion of 2PNs formed over the injected oocytes	16-18 hours
Secondary	Cleavage rate	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes	3 days
Secondary	Blastulation rate	Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3	5-6 days
Secondary	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
Secondary	Pregnancy rate	Defined as clinical pregnancy per embryo(s) transfer	14 days following embryo transfer
Secondary	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]