ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03360526
Date of registration:	28/11/2017
Prospective Registration:	No
Primary sponsor:	Ganin Fertility Center
Public title:	What is the Best Sperm Source and Way of Sperm Selection in Cases With Abnormal sORP Levels on the Day of ICSI?
Scientific 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?
Date of first enrolment:	November 20, 2017
Target sample size:	820
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03360526
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Egypt

Contacts

Name:	Hosam Zaki, MSc, FRCOG
Address:
Telephone:
Email:
Affiliation:	Ganin Fertility Center, Cairo, Egypt

Name:	Khaled Elqusi, BSc
Address:
Telephone:
Email:
Affiliation:	Ganin Fertility Center, Cairo, Egypt

Name:	Eman Hasanen, BSc
Address:
Telephone:
Email:
Affiliation:	Ganin Fertility Center, Cairo, Egypt

Name:	Ashok Agarwal, Ph.D
Address:
Telephone:
Email:
Affiliation:	American Center of reproductive medicine, Cleveland Clinic, Ohio, USA

Name:	Ralph Henkel, PhD
Address:
Telephone:
Email:
Affiliation:	University of the Western Cape

Name:	Eman Hasanen, BSc
Address:
Telephone:	00201282012291
Email:	em.saberh@gmail.com
Affiliation:

Name:	Hosam Zaki, MSc, FRCOG
Address:
Telephone:	+201222150018
Email:	hosamz@tedata.net.eg
Affiliation:

Name:	Hanaa Elkhedr, ABB( ELD)
Address:
Telephone:
Email:
Affiliation:	Ganin Fertility Center, Cairo, Egypt

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Oxidative Stress

Intervention(s)

Device: PICSI

Procedure: TESA

Primary Outcome(s)

Ongoing pregnancy rate [Time Frame: 20 weeks of gestation]

Secondary Outcome(s)

Pregnancy rate [Time Frame: 14 days following embryo transfer]

Blastulation rate [Time Frame: 5-6 days]

Cleavage rate [Time Frame: 3 days]

Fertilization rate [Time Frame: 16-18 hours]

Blastocyst quality rate [Time Frame: 5-6 days]

Implantation rate [Time Frame: 6- 8 weeks following embryo transfer]]

Secondary ID(s)

EMSH25390

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Cleveland Clinic

University of the Western Cape

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.