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

Not Applicable

Completed

• Conditions: Sperm DNA Fragmentation
• Interventions: Other: PICSI; Other: MACS

• Registration Number: NCT03398317
• Lead Sponsor: Ganin Fertility Center

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-01-07
• Study First Submitted QC: 2018-01-07
• Study First Posted: 2018-01-12
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-18
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICSI	PICSI	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
MACS	MACS	Semen processing is done by double layer density gradient method. The resulted pellet is labeled with annexin V microbeads followed by separation on MACS Column, the eluted fraction contains non apoptotic sperm suitable for Oocyte injection.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	20 weeks of gestation	Defined as the proportion of pregnancies that completed more than 20 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Comparison of Blastocyst quality rate	5-6 days	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
Comparison of Pregnancy rate	14 days following embryo transfer	Defined as clinical pregnancy per transfer
Comparison of implantation rate	6- 8 weeks following embryo transfer	Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
Comparison of cleavage rate	3 days	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes
Comparison of Blastulation rate	5-6 days	Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, Egypt