What is the Best Sperm Source and Way of Sperm Selection in Cases With Abnormal sORP Levels on the Day of ICSI?
1 other identifier
interventional
820
1 country
1
Brief Summary
Does the level of statistic oxidation reduction potential (sORP) affects the choice of sperm source or sperm selection method used during ICSI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2017
CompletedFirst Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedJanuary 23, 2019
January 1, 2019
2.1 years
November 28, 2017
January 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy rate
Defined as the proportion of pregnancies that had completed ≥20 weeks of gestation.
20 weeks of gestation
Secondary Outcomes (6)
Fertilization rate
16-18 hours
Cleavage rate
3 days
Blastulation rate
5-6 days
Blastocyst quality rate
5-6 days
Pregnancy rate
14 days following embryo transfer
- +1 more secondary outcomes
Study Arms (2)
PICSI
ACTIVE COMPARATORPhysiological ICSI
TESA
EXPERIMENTALTesticular sperm aspiration
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ganin Fertility Centerlead
- The Cleveland Cliniccollaborator
- University of the Western Capecollaborator
Study Sites (1)
Ganin Fertility center
Maadi, Cairo Governorate, 12345, Egypt
Related Publications (4)
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.
PMID: 27260688BACKGROUNDAgarwal 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.
PMID: 27839743BACKGROUNDNatali 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.
PMID: 21256575BACKGROUNDT. Cozzubbo, Q.V. Neri, M. Goldstein, Z. Rosenwaks, G.D. Palermo. Topographic mapping of sperm DNA fragmentation within the male genital tract.
BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Eman Hasanen, BSc
Ganin Fertility Center, Cairo, Egypt
- STUDY CHAIR
Hosam Zaki, MSc, FRCOG
Ganin Fertility Center, Cairo, Egypt
- 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
Ralph Henkel, PhD
University of the Western Cape
- PRINCIPAL INVESTIGATOR
Hanaa Elkhedr, ABB( ELD)
Ganin Fertility Center, Cairo, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 4, 2017
Study Start
November 20, 2017
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
January 23, 2019
Record last verified: 2019-01