Clinical trial NCT04482517: Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.
Official title: Reproductive Outcomes of Different Sperm Selection Techniques; Density Gradient Centrifugation, Testicular Sperm, PICSI, and MACS for ICSI Patients With Abnormal Sperm DNA Fragmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
Keywords: Sperm DNA fragmentation
PICSI
MACS
Sperm Selection
DGC
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.


Eligibility criteria: Inclusion Criteria:

* Female age was ≤37 years
* Female should has 5≥ metaphase II oocytes
* Males having abnormal SDF levels ≥ 20.3% by TUNEL assay
* Abstinence from 1 to 2 days
* Males having at least 1 million total motile progressive count

Exclusion Criteria:

* 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: Clinical pregnancy rate
timeFrame: 14 days following embryo transfer
measure: Implantation rate
timeFrame: 6- 8 weeks following embryo transfer
measure: Ongoing pregnancy rate
timeFrame: 20 weeks of gestation
Secondary outcomes:
measure: Cleavage rate
timeFrame: 3 days
measure: Blastulation rate
timeFrame: 5-6 days
measure: High quality blastocyst rate
timeFrame: 5-6 days
measure: Miscarriage rate
timeFrame: 20 weeks of gestation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
state: Maadi
Study officials:
affiliation: Ganin Fertility Center
name: Eman Hasanen
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: khaled Elqusi
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Salma Eltanbouly
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Samar Gamal
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Abd ElGhafar Hussin
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hanaa Elkhadr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki
role: STUDY_CHAIR
References:
citation: Hozyen M, Hasanen E, Elqusi K, ElTanbouly S, Gamal S, Hussin AG, AlKhader H, Zaki H. Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients with Abnormal Sperm DNA Fragmentation: a Randomized Controlled Trial. Reprod Sci. 2022 Jan;29(1):220-228. doi: 10.1007/s43032-021-00642-y. Epub 2021 Jun 2.