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Oxidative StressNCT03360526

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

A study testing PICSI and TESA in people with Oxidative Stress, run by Ganin Fertility Center at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years, men only
Conditions the study is for
Oxidative Stress
What is being tested?
PICSI and TESA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
820 participants
Where
1 siteEgypt
Study dates
20 Nov 2017to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Hosam Zaki, MSc, FRCOG contact

+201222150018

hosamz@tedata.net.eg

Eman Hasanen, BSc contact

+201282012291

em.saberh@gmail.com

Egypt1 site, 1 recruiting

  • Ganin Fertility center

    Maadi, Cairo Governorate, 12345

    Eman Hasanen, BSc, 00201282012291, em.saberh@gmail.com

    Hosam Zaki, MD, 00201222150018, hosamz@tedata.net.eg

    Recruiting

Other trials in Egypt

About this study

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?

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

Read the 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.

Being tested
PICSI, TESA
Keywords
PICSI, ORP, TESA, seminal oxidation reduction potential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PICSIDevice

    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.

  • TESAProcedure or surgery

    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.

Study groups in NCT03360526
Study groupRoleWhat they receive
PICSIActive comparatorPhysiological ICSI
Receives: Device: PICSI
TESAExperimentalTesticular sperm aspiration
Receives: Procedure: TESA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ongoing pregnancy rate

    Defined as the proportion of pregnancies that had completed ≥20 weeks of gestation.

    Measured: 20 weeks of gestation

Secondary outcomes (6)

  1. Fertilization rate

    Defined as the proportion of 2PNs formed over the injected oocytes

    Measured: 16-18 hours

  2. Cleavage rate

    Defined as the proportion of cleaved embryos on day 3 over the injected oocytes

    Measured: 3 days

  3. Blastulation rate

    Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3

    Measured: 5-6 days

  4. 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

    Measured: 5-6 days

  5. Pregnancy rate

    Defined as clinical pregnancy per embryo(s) transfer

    Measured: 14 days following embryo transfer

  6. 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.

    Measured: 6- 8 weeks following embryo transfer]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2017
  2. Study start20 Nov 2017
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
820 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03360526
Sponsor's protocol ID
EMSH25390
Status last verified
Jan 2019
First submitted
28 Nov 2017
Last updated
23 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 27260688

  • 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.

    PubMed 27839743

  • 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.

    PubMed 21256575

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

Questions about this trial

What is this clinical trial studying?

A study testing PICSI and TESA in people with Oxidative Stress, run by Ganin Fertility Center at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hosam Zaki, MSc, FRCOG (+201222150018, hosamz@tedata.net.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing pregnancy rate (time frame: 20 weeks of gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360526, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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