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

Not Applicable

Completed

• Conditions: Infertility, Male
• Interventions: Other: Density Gradient Centrifugation; Other: Testicular sperm; Other: Magnetic activated cell sorting; Other: Physiological ICSI

• Registration Number: NCT04482517
• Lead Sponsor: Ganin Fertility Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-22
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Density Gradient Centrifugation (DGC)	Density Gradient Centrifugation	Using the routine DGC sperm processing only
Testicular sperm (Testi)	Testicular sperm	Using testicular sperm not ejaculated sperm
Magnetic Activated Cell Sorting (MACS)	Magnetic activated cell sorting	Using MACS for selecting sperm with lower sperm DNA fragmentation
Physiological ICSI (PICSI)	Physiological ICSI	Using PICSI dish for selecting sperm with lower sperm DNA fragmentation

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	14 days following embryo transfer	Defined as clinical pregnancy per transfer
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.
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
Blastulation rate	5-6 days	Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3
High quality blastocyst 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
Cleavage rate	3 days	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes
Miscarriage rate	20 weeks of gestation	Defined as the proportion of miscarried cases

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, Maadi, Egypt