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

Primary Purpose

Infertility, Male

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Density Gradient Centrifugation

Physiological ICSI

Magnetic activated cell sorting

Testicular sperm

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring Sperm DNA fragmentation, PICSI, MACS, Sperm Selection, DGC

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ganin Fertility Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Active Comparator

Arm Label

Density Gradient Centrifugation (DGC)

Physiological ICSI (PICSI)

Magnetic Activated Cell Sorting (MACS)

Testicular sperm (Testi)

Arm Description

Using the routine DGC sperm processing only

Using PICSI dish for selecting sperm with lower sperm DNA fragmentation

Using MACS for selecting sperm with lower sperm DNA fragmentation

Using testicular sperm not ejaculated sperm

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

Defined as clinical pregnancy per transfer

Implantation rate

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

Defined as the proportion of pregnancies that completed more than 20 weeks of gestation

Secondary Outcome Measures

Cleavage rate

Defined as the proportion of cleaved embryos on day 3 over the injected oocytes

Blastulation rate

Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3

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

Miscarriage rate

Defined as the proportion of miscarried cases

Full Information

NCT ID

NCT04482517

First Posted

July 18, 2020

Last Updated

July 21, 2020

Sponsor

Ganin Fertility Center

1. Study Identification

Unique Protocol Identification Number

NCT04482517

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ganin Fertility Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Male

Keywords

Sperm DNA fragmentation, PICSI, MACS, Sperm Selection, DGC

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

320 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Density Gradient Centrifugation (DGC)

Arm Type

Other

Arm Description

Using the routine DGC sperm processing only

Arm Title

Physiological ICSI (PICSI)

Arm Type

Active Comparator

Arm Description

Using PICSI dish for selecting sperm with lower sperm DNA fragmentation

Arm Title

Magnetic Activated Cell Sorting (MACS)

Arm Type

Active Comparator

Arm Description

Using MACS for selecting sperm with lower sperm DNA fragmentation

Arm Title

Testicular sperm (Testi)

Arm Type

Active Comparator

Arm Description

Using testicular sperm not ejaculated sperm

Intervention Type

Other

Intervention Name(s)

Density Gradient Centrifugation

Other Intervention Name(s)

DGC

Intervention Description

Semen processing is done by double layer density gradient method.

Intervention Type

Other

Intervention Name(s)

Physiological ICSI

Other Intervention Name(s)

PICSI

Intervention Description

Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head

Intervention Type

Other

Intervention Name(s)

Magnetic activated cell sorting

Other Intervention Name(s)

MACS

Intervention Description

Sperm selection by using Annexin V micro-beads and separation columns

Intervention Type

Other

Intervention Name(s)

Testicular sperm

Other Intervention Name(s)

Testi

Intervention Description

Using testicular sperm retrieved by TESA or TESE

Primary Outcome Measure Information:

Title

Clinical pregnancy rate

Description

Defined as clinical pregnancy per transfer

Time Frame

14 days following embryo transfer

Title

Implantation rate

Description

Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.

Time Frame

6- 8 weeks following embryo transfer

Title

Ongoing pregnancy rate

Description

Defined as the proportion of pregnancies that completed more than 20 weeks of gestation

Time Frame

20 weeks of gestation

Secondary Outcome Measure Information:

Title

Cleavage rate

Description

Defined as the proportion of cleaved embryos on day 3 over the injected oocytes

Time Frame

3 days

Title

Blastulation rate

Description

Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3

Time Frame

5-6 days

Title

High quality blastocyst rate

Description

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

Time Frame

5-6 days

Title

Miscarriage rate

Description

Defined as the proportion of miscarried cases

Time Frame

20 weeks of gestation

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials: