Clinical trial NCT03398317: Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI
Official title: PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sperm DNA Fragmentation
Keywords: SDF
DFI
sperm selection
PICSI
MACS
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: University of the Western Cape
First posted: 2018-01-12
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 20 weeks of gestation
Secondary outcomes:
measure: Comparison of cleavage rate
timeFrame: 3 days
measure: Comparison of Blastulation rate
timeFrame: 5-6 days
measure: Comparison of Blastocyst quality rate
timeFrame: 5-6 days
measure: Comparison of Pregnancy rate
timeFrame: 14 days following embryo transfer
measure: Comparison of implantation rate
timeFrame: 6- 8 weeks following embryo transfer
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
Study officials:
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Hosam Zaki, MSc, FRCOG
role: STUDY_CHAIR
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Eman Hasanen, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Khaled El Qusi, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Abd El Ghafar Hussin, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Salma El Tanbouly, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: American Center of Reproductive Medicine, Cleveland Clinic
name: Ashok Agarwal, PhD
role: STUDY_DIRECTOR
affiliation: University of the Western Cape
name: Ralph Henkel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center, Cairo, Egypt
name: Hanaa Alkhader
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benchaib M, Braun V, Lornage J, Hadj S, Salle B, Lejeune H, Guerin JF. Sperm DNA fragmentation decreases the pregnancy rate in an assisted reproductive technique. Hum Reprod. 2003 May;18(5):1023-8. doi: 10.1093/humrep/deg228.
citation: Baldi and Muratori (2013) Genitic Damage in Human Spermatozoa. USA, NY : Springer Science & Business Media.
citation: Hasanen E, Elqusi K, ElTanbouly S, Hussin AE, AlKhadr H, Zaki H, Henkel R, Agarwal A. PICSI vs. MACS for abnormal sperm DNA fragmentation ICSI cases: a prospective randomized trial. J Assist Reprod Genet. 2020 Oct;37(10):2605-2613. doi: 10.1007/s10815-020-01913-4. Epub 2020 Aug 8.