Clinical trial NCT03360526: What is the Best Sperm Source and Way of Sperm Selection in Cases With Abnormal sORP Levels on the Day of ICSI?
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oxidative Stress
Keywords: PICSI
ORP
TESA
seminal oxidation reduction potential
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: University of the Western Cape
First posted: 2017-12-04
Enrollment: 820
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 20 weeks of gestation
Secondary outcomes:
measure: Fertilization rate
timeFrame: 16-18 hours
measure: Cleavage rate
timeFrame: 3 days
measure: Blastulation rate
timeFrame: 5-6 days
measure: Blastocyst quality rate
timeFrame: 5-6 days
measure: Pregnancy rate
timeFrame: 14 days following embryo transfer
measure: Implantation rate
timeFrame: 6- 8 weeks following embryo transfer]
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Ganin Fertility center
state: Cairo
Study officials:
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Eman Hasanen, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Hosam Zaki, MSc, FRCOG
role: STUDY_CHAIR
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Khaled Elqusi, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: American Center of reproductive medicine, Cleveland Clinic, Ohio, USA
name: Ashok Agarwal, Ph.D
role: STUDY_DIRECTOR
affiliation: University of the Western Cape
name: Ralph Henkel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Hanaa Elkhedr, ABB( ELD)
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: T. Cozzubbo, Q.V. Neri, M. Goldstein, Z. Rosenwaks, G.D. Palermo. Topographic mapping of sperm DNA fragmentation within the male genital tract.