Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Different Sperm Processing Methods in ICSI Outcome.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668106
Recruitment Status : Unknown
Verified September 2018 by Ahmed Saad, Benha University.
Recruitment status was:  Recruiting
First Posted : September 12, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Hawaa Fertility Center
Information provided by (Responsible Party):
Ahmed Saad, Benha University

Brief Summary:
A total 180 semen samples from couples diagnosed with unexplained infertility were SDF index tested , then total 120 semen samples of patients' husbands with abnormal SDF index were randomly divided and then processed by swim up, sperm gradient centrifugation and Zeta methods. SDF and ICSI outcomes are monitored after semen processing.

Condition or disease Intervention/treatment Phase
Sperm DNA Fragmentation Procedure: sperm processing method Phase 2 Phase 3

Detailed Description:
A total 180 semen samples from couples diagnosed with unexplained infertility were SDF index tested , then total 120 semen samples of patients' husbands with abnormal SDF index were randomly divided and then processed by swim up (G1/ n=40), sperm gradient centrifugation (G2/ n=40) and Zeta (G3/ n=40) methods. SDF test was assessed by Halosperm kit, whereas sperm morphology was assessed by spermac stain according to strict criteria. Fertilization, division, blastulation, implantation and pregnancy rates will be tabulated and statistically tested.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Different Sperm Processing Methods ( Swim up, Zeta, Sperm Gradient Centrifugation ) in ICSI Outcome. "A Sperm DNA Perspective"
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
Active Comparator: swim up method
Measure volume using a sterile 2 mL pipet.Transfer specimen from a plastic cup to a sterile 15 mL- conical centrifuge tube. Gently mix the specimen with equal volume of Sperm Washing Media. Centrifuge the tubes at 1500 rpm for 10 minutes.Carefully aspirate the supernatant without disturbing the pellet and resuspend the pellet in 50mcm of fresh washing medium, then place layer of 0.5 ml of washing medium gently on the surface. Incubate the tubes at a 45° angle for 1 hour for swim-up in vertical rack in a 37°C incubator. After the incubation period, aspirate the entire supernatant from the round bottom tube. Aliquots of the detached sperm were analyzed by halosperm assay for DNA fragmentation another aliquots of same supernatant were used for ICSI then fertilization, division, blastulation, pregnancy and implantation rates were tabulated and statistically tested.
Procedure: sperm processing method
different sperm processing method for selcting most proper sperm for ICSI

Active Comparator: sperm gradient centrifugation

PureSperm gradients 40 % and 80 % were used for the experiment. All procedures were conducted under sterile conditions. Using a sterile pipette, 2.0 mL of the "lower layer" (80% PureSperm gradient) was transferred into a conical centrifuge tube.

Using a new sterile pipette, 2.0 mL of the "upper layer" (40% PureSperm gradient) was gently dispensed on top of the lower layer. A liquefied semen sample was then placed on top of the upper layer and the tube was centrifuged for 20 minutes at 300g. The upper and lower layers were carefully aspirated without disturbing the pellet. Using a transfer pipette, 2-3 mL of Ham's F10 +10% HAS was added to the pellet and the resuspended pellet was centrifuged for 7 minutes at 300g. The supernatant was then removed and the pellet was suspended in a volume of 0.5 mL of Ham's F10 + FCS 10%. Aliquots of the detached sperm were dealt with like previous arm

Procedure: sperm processing method
different sperm processing method for selcting most proper sperm for ICSI

Active Comparator: zeta method

sperm samples were diluted 5 million in 1 ml. To induce a positive charge, the tube was placed inside a latex glove up to the cap and grasping the cap, the tube was rotated two or three turns and rapidly pulled out. Each tube was kept at room temperature for 1 minute to allow adherence of the charged sperm to the wall of the centrifuge tube.

Tubes were hold by the cap to avoid grounding of the tube. After 1 minute the tubes were centrifuged at 200g for 5 minutes. Then, the medium and pellet were discarded in order to discard non adhering sperm and other cells. The surface of tube was washed by 0.2ml of Ham's F10+ FCS 10% in order to neutralize the charge on the wall of the tube and detach the adhering sperm.

The collected medium at the bottom of each tube was repipetted and used to rinse the wall of the same tube several times to increase the number of recovered sperm . Aliquots of the detached sperm were dealt with like previous arm

Procedure: sperm processing method
different sperm processing method for selcting most proper sperm for ICSI




Primary Outcome Measures :
  1. Sperm DNA fragmentation [ Time Frame: 30 minutes ]
    measure sperm integrity by halosperm assay


Secondary Outcome Measures :
  1. Oocyte fertilization rate [ Time Frame: day 1 ]
    no. of oocytes fertilized /total no. of oocytes

  2. Blastulation rate [ Time Frame: day 5 ]
    no of embryos blastulated / total no. of embryos

  3. pregnancy rate [ Time Frame: 15 days ]
    no of pregnant cases\ all no. of cases



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 37 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unexplained infertile couples for 2 years
  • age from 20 years old to 37 years old

Exclusion Criteria:

  • endometriosis cases
  • uterine factors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668106


Contacts
Layout table for location contacts
Contact: Ahmed Saad 0133194042 drahmedsaad@live.com
Contact: Sahar Afify 01206260974 Saharafify@yahoo.com

Locations
Layout table for location information
Egypt
Ahmed Saad Recruiting
Banha, Qalubiya, Egypt, 13512
Contact: Ahmed Saad    133194042    drahmedsaad@live.com   
Sponsors and Collaborators
Benha University
Hawaa Fertility Center
Layout table for additonal information
Responsible Party: Ahmed Saad, Ass. prof. OB & GYN, Benha University
ClinicalTrials.gov Identifier: NCT03668106    
Other Study ID Numbers: Hawaa-4
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No