Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI

Sperm DNA Fragmentation Clinical Trial

Official title:

PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398317
• Other study ID #: GFC - 002
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: July 2020
• Source: Ganin Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.

Description:

Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester.

Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates.

A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation.

In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Males diagnosed of abnormal DNA fragmentation index ( > 19%).

• Males with mild to moderate OTA (oligoteratoasthenozoospermia).

• Male aged 18-60 years.

• Female aged 18-40 years.

• Normo responder ( > 5 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:

Males with normalDNA fragmentation index (<19%)at the initial assessment.

• 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 previous uterine infection

• Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Related Conditions & MeSH terms

• Sperm DNA Fragmentation

Intervention

Other:
• PICSI
sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
• MACS
sperm selection using MACS for selecting sperm with lower DNA fragmentation index

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	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 (2)

Baldi and Muratori (2013) Genitic Damage in Human Spermatozoa. USA, NY : Springer Science & Business Media.

Benchaib M, Braun V, Lornage J, Hadj S, Salle B, Lejeune H, Guérin JF. Sperm DNA fragmentation decreases the pregnancy rate in an assisted reproductive technique. Hum Reprod. 2003 May;18(5):1023-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Defined as the proportion of pregnancies that completed more than 20 weeks of gestation	20 weeks of gestation
Secondary	Comparison of cleavage rate	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes	3 days
Secondary	Comparison of 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	Comparison of 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	Comparison of Pregnancy rate	Defined as clinical pregnancy per transfer	14 days following embryo transfer
Secondary	Comparison of implantation rate	Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.	6- 8 weeks following embryo transfer