Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.

Infertility, Male Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482517
• Other study ID #: MH-005
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 1, 2018

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Other:
• Density Gradient Centrifugation
Semen processing is done by double layer density gradient method.
• Physiological ICSI
Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head
• Magnetic activated cell sorting
Sperm selection by using Annexin V micro-beads and separation columns
• Testicular sperm
Using testicular sperm retrieved by TESA or TESE

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Defined as clinical pregnancy per transfer	14 days following embryo transfer
Primary	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
Primary	Ongoing pregnancy rate	Defined as the proportion of pregnancies that completed more than 20 weeks of gestation	20 weeks of gestation
Secondary	Cleavage rate	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes	3 days
Secondary	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	High quality blastocyst 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	Miscarriage rate	Defined as the proportion of miscarried cases	20 weeks of gestation